Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8).
Attar A, Mirhosseini SA, Mathur A, Dowlut S, Monabati A, Kasaei M, Abtahi F, Kiwan Y, Vosough M, Azarpira N
- DOI
- 10.1136/bmj-2024-083382
- Record issued
- 2026-08-15
- Engine
- 7.39.0
- Exported
- 2026-09-22
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/faab8356-55db-4c7a-8c8e-bfdd83a38e9f is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 4 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
This is a well-conducted and transparently reported Phase 3 randomized clinical trial of intracoronary Wharton's jelly-derived mesenchymal stem cells for post-MI heart failure prevention. The manuscript demonstrates strong rigor across all eight dimensions, with clear randomization, blinding, sample size justification, ethical approvals, and data availability. Minor copyedit issues (typos and apparent formatting errors in Table 1 and a CI in the Discussion) do not undermine the scientific integrity but warrant correction.
Both reviewers independently scored all dimensions as 'pass' with high confidence, and their evidence was consistent; no divergence required reconciliation. The study type is interventional (randomized controlled trial). Non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded from scoring. The statistics verification covered only a subset of reported tests (7 with test statistics/df or effect estimates with CIs); other p-values were not machine-verified.
Numerical inconsistencies
1 finding · worst lowValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
- Internal contradictions in the reported numbersAssessed
Recomputed 7 tests: 7 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 6 via agent-written checks.
- CONSISTENTreported p = .024 · recomputed p = .022Recomputed hazard ratio 0.43 (95% CI 0.21–0.89), reported p=0.024
“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024”
Taken as given: 0.21–0.89 is a two-sided 95% confidence interval for the hazard ratio of 0.43, not a range, an IQR, or a different interval level; the hazard ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.024 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.43, 0.21, 0.89, 1) - CONSISTENTreported p = .024 · recomputed p = .022Reviewers 1, 2Primary endpoint hazard ratio p-value
“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024”
Taken as given: The hazard ratio is 0.43 with 95% CI 0.21 to 0.89.; The CI is two-sided at 95%.; The p-value is two-sided.Method: Recomputed p-value from the hazard ratio and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(0.43, 0.21, 0.89, 1) - CONSISTENTreported p = .015 · recomputed p = .018Reviewers 1, 2Readmission for heart failure hazard ratio p-value
“readmission to hospital for heart failure (0.92 v 4.20 per 100 person years; 0.22, 0.06 to 0.74; P=0.015)”
Taken as given: The hazard ratio is 0.22 with 95% CI 0.06 to 0.74.; The CI is two-sided at 95%.; The p-value is two-sided.Method: Recomputed p-value from the hazard ratio and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(0.22, 0.06, 0.74, 1) - CONSISTENTreported p = .012 · recomputed p = .012Reviewers 1, 2Composite endpoint hazard ratio p-value
“composite endpoint of cardiovascular mortality and readmission for myocardial infarction or heart failure (2.80 v 7.16 per 100 person years; 0.39, 0.19 to 0.82; P=0.012)”
Taken as given: The hazard ratio is 0.39 with 95% CI 0.19 to 0.82.; The CI is two-sided at 95%.; The p-value is two-sided.Method: Recomputed p-value from the hazard ratio and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(0.39, 0.19, 0.82, 1) - CONSISTENTreported p = .100 · recomputed p = .093Reviewers 1, 2Readmission for myocardial infarction hazard ratio p-value
“readmission to hospital for myocardial infarction (1.23 v 3.06 per 100 person years; hazard ratio 0.40, 0.14 to 1.19; P=0.10)”
Taken as given: The hazard ratio is 0.40 with 95% CI 0.14 to 1.19.; The CI is two-sided at 95%.; The p-value is two-sided.Method: Recomputed p-value from the hazard ratio and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(0.40, 0.14, 1.19, 1) - CONSISTENTreported p = .860 · recomputed p = .853Reviewers 1, 2All-cause mortality hazard ratio p-value
“all cause mortality (1.81 v 1.66 per 100 person years; 1.10, 0.40 to 3.02; P=0.86)”
Taken as given: The hazard ratio is 1.10 with 95% CI 0.40 to 3.02.; The CI is two-sided at 95%.; The p-value is two-sided.Method: Recomputed p-value from the hazard ratio and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(1.10, 0.40, 3.02, 1) - CONSISTENTreported p = .570 · recomputed p = .570Reviewers 1, 2Cardiovascular mortality hazard ratio p-value
“cardiovascular mortality (0.91 v 1.33 per 100 person years; 0.68, 0.18 to 2.57; P=0.57)”
Taken as given: The hazard ratio is 0.68 with 95% CI 0.18 to 2.57.; The CI is two-sided at 95%.; The p-value is two-sided.Method: Recomputed p-value from the hazard ratio and its 95% CI using the normal approximation for the log hazard ratio.How we recomputed it: pCI(0.68, 0.18, 2.57, 1)
- lowinternal contradictionIn the Discussion, the BAMI trial readmission for heart failure CI is reported as '8.1% (4.7% to 2.5%; n=15)', where the upper bound is lower than the lower bound, suggesting a typographical error.
“8.1% (4.7% to 2.5%; n=15)”
DiscussionFind in source - lowinternal contradictionIn Table 1, the row for 'eGFR <60 mm/min/1.73 m2' shows '18 (134)' for the intervention group and '39 (1)' for the control group, which appear to be typographical errors in the percentages.
“eGFR <60 mm/min/1.73 m 2 | 18 (134) | 39 (1) | 57 (14)”
Table 1Find in source
Overstated conclusions
None foundConclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.
Checked — nothing surfaced.
11 major claims checked against the paper's own evidence: all adequately supported.
- supportedReviewers 1, 2Intracoronary infusion of Wharton's jelly derived mesenchymal stem cells significantly reduced the risk of incidence of heart failure.The primary endpoint analysis shows a significant reduction with HR 0.43 (95% CI 0.21-0.89, P=0.024).Evidence: Abstract reports HR 0.43, 95% CI 0.21-0.89, P=0.024 for heart failure incidence.
“Intracoronary infusion of mesenchymal stem cells had a preventive effect for incidence of heart failure (2.77 v 6.48 per 100 person years; hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024)”
AbstractFind in source - supportedReviewer 1Intracoronary infusion of Wharton's jelly derived mesenchymal stem cells significantly reduced readmission to hospital for heart failure.Secondary endpoint shows significant reduction with HR 0.22 (95% CI 0.06-0.74, P=0.015).Evidence: Abstract reports HR 0.22, 95% CI 0.06-0.74, P=0.015 for readmission for heart failure.
“readmission to hospital for heart failure (0.92 v 4.20 per 100 person years; 0.22, 0.06 to 0.74; P=0.015)”
AbstractFind in source - supportedReviewers 1, 2Intracoronary infusion of Wharton's jelly derived mesenchymal stem cells significantly reduced the composite endpoint of cardiovascular mortality and readmission for myocardial infarction or heart failure.Composite endpoint shows significant reduction with HR 0.39 (95% CI 0.19-0.82, P=0.012).Evidence: Abstract reports HR 0.39, 95% CI 0.19-0.82, P=0.012 for composite endpoint.
“composite endpoint of cardiovascular mortality and readmission for myocardial infarction or heart failure (2.80 v 7.16 per 100 person years; 0.39, 0.19 to 0.82; P=0.012)”
AbstractFind in source - supportedReviewer 1Left ventricular ejection fraction in the intervention group showed a significantly greater improvement from baseline at six months compared with the control group.Linear regression analysis shows β=5.88, 95% CI 4.00-7.76, P<0.001.Evidence: Abstract reports β=5.88, 95% CI 4.00-7.76, P<0.001.
“Left ventricular ejection fraction in the intervention group showed a significantly greater improvement from baseline at six months compared with the control group (β=5.88, 95% confidence interval 4.00 to 7.76; P<0.001)”
AbstractFind in source - supportedReviewer 1The intervention did not have a statistically significant effect on all-cause mortality.The reported HR 1.10 (95% CI 0.40-3.02, P=0.86) is not significant.Evidence: Abstract reports HR 1.10, 95% CI 0.40-3.02, P=0.86 for all-cause mortality.
“all cause mortality (1.81 v 1.66 per 100 person years; 1.10, 0.40 to 3.02; P=0.86)”
AbstractFind in source - supportedReviewer 1The intervention did not have a statistically significant effect on cardiovascular mortality.The reported HR 0.68 (95% CI 0.18-2.57, P=0.57) is not significant.Evidence: Abstract reports HR 0.68, 95% CI 0.18-2.57, P=0.57 for cardiovascular mortality.
“cardiovascular mortality (0.91 v 1.33 per 100 person years; 0.68, 0.18 to 2.57; P=0.57)”
AbstractFind in source - supportedReviewer 1The intervention did not have a statistically significant effect on readmission to hospital for myocardial infarction.The reported HR 0.40 (95% CI 0.14-1.19, P=0.10) is not significant.Evidence: Abstract reports HR 0.40, 95% CI 0.14-1.19, P=0.10 for readmission for MI.
“readmission to hospital for myocardial infarction (1.23 v 3.06 per 100 person years; hazard ratio 0.40, 0.14 to 1.19; P=0.10)”
AbstractFind in source - supportedReviewer 2The intervention significantly reduced readmission to hospital for heart failure.Secondary endpoint analysis shows a significant reduction with HR 0.22 (95% CI 0.06-0.74, P=0.015).Evidence: Abstract reports HR 0.22, 95% CI 0.06 to 0.74, P=0.015 for readmission for heart failure.
“readmission to hospital for heart failure (0.92 v 4.20 per 100 person years; 0.22, 0.06 to 0.74; P=0.015)”
AbstractFind in source - supportedReviewer 2Left ventricular ejection fraction improved significantly more in the intervention group than in the control group.Linear regression analysis shows a significant difference with β=5.88 (95% CI 4.00-7.76, P<0.001).Evidence: Abstract reports β=5.88, 95% CI 4.00 to 7.76, P<0.001 for LVEF improvement.
“Left ventricular ejection fraction in the intervention group showed a significantly greater improvement from baseline at six months compared with the control group (β=5.88, 95% confidence interval 4.00 to 7.76; P<0.001)”
AbstractFind in source - supportedReviewer 2The intervention did not have a statistically significant effect on all-cause mortality, cardiovascular mortality, or readmission for myocardial infarction.The reported hazard ratios and p-values for these endpoints are not statistically significant, consistent with the claim.Evidence: Abstract reports HR 1.10 (P=0.86) for all-cause mortality, HR 0.68 (P=0.57) for cardiovascular mortality, and HR 0.40 (P=0.10) for readmission for MI.
“The intervention did not have a statistically significant effect on readmission to hospital for myocardial infarction (1.23 v 3.06 per 100 person years; hazard ratio 0.40, 0.14 to 1.19; P=0.10), all cause mortality (1.81 v 1.66 per 100 person years; 1.10, 0.40 to 3.02; P=0.86), or cardiovascular mortality (0.91 v 1.33 per 100 person years; 0.68, 0.18 to 2.57; P=0.57)”
AbstractFind in source - supportedReviewer 2The technique may serve as a valuable adjunctive procedure after myocardial infarction to prevent the development of heart failure.The conclusion is supported by the significant reduction in heart failure incidence and related endpoints, though the claim of 'valuable adjunctive procedure' is a reasonable interpretation.Evidence: The primary and secondary endpoint results support the conclusion.
“suggesting that this technique may serve as a valuable adjunctive procedure after myocardial infarction to prevent the development of heart failure and reduce the risk of future adverse events.”
ConclusionFind in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- ADEQUATESurrogate endpointThe primary endpoint is the incidence of heart failure, a hard clinical outcome, not a surrogate. Secondary endpoints include readmission for heart failure, mortality, and composite outcomes. The paper also reports LVEF change as a secondary endpoint, but the primary efficacy claim is based on clinical events.
“The primary endpoint was the incidence of heart failure, defined as a clinical condition with symptoms of dyspnoea at rest or during exertion and evidence of cardiogenic pulmonary or systemic congestion necessitating an outpatient visit, hospital admission, or emergency department visit during which medical therapy was administered for symptoms and signs consistent with cardiac decompensation or impaired cardiac function.”
- ADEQUATEEffect sizeThe primary effect is a hazard ratio of 0.43 for heart failure incidence, with absolute rates of 2.77 vs 6.48 per 100 person-years, representing a clinically meaningful reduction. The effect is statistically significant and anchored to a clinical outcome.
“Intracoronary infusion of mesenchymal stem cells had a preventive effect for incidence of heart failure (2.77 v 6.48 per 100 person years; hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024)”
Data authenticity concerns
None foundAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
Checked — nothing surfaced.
Reporting gaps
None foundRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
Checked — nothing surfaced.
The paper cites prior research including the BAMI trial and a meta-analysis, acknowledges limitations of previous studies (small sample sizes, surrogate endpoints, short follow-up), and builds a logical rationale for using clinical endpoints and Wharton's jelly-derived MSCs. The hypothesis follows from the cited evidence.
“The BAMI trial, the largest phase 3 trial in this area, used total mortality as its primary endpoint but did not show a significant benefit, despite a significant reduction in hospital admissions for heart failure after intracoronary infusion of bone marrow derived mononuclear cells.”
“Building on these insights, we designed a phase 3 clinical trial with long term follow-up to assess the effect of intracoronary infusion of Wharton’s jelly derived mesenchymal stem cells on the development of post-myocardial infarction heart failure.”
“Despite growing interest, most clinical trials investigating stem cell therapy have been limited by small sample sizes and a focus on surrogate endpoints such as cardiac biomarkers, left ventricular ejection fraction, or scar size.”
“These findings highlight the challenges of using mortality as a primary endpoint in cell therapy trials and suggest that incidence of heart failure may be a more appropriate and sensitive clinical outcome for evaluating efficacy.”
“Our previous phase 2 trial showed the effectiveness of intracoronary infusion of Wharton’s jelly derived mesenchymal stem cells in improving left ventricular ejection fraction after myocardial infarction.”
Randomization used permuted block randomization with a web-based system, and the unit is the patient. Blinding is described as single-blind with a rationale for not blinding patients (sham not permitted). Power analysis is provided with assumptions. Inclusion/exclusion criteria are pre-specified. Outlier handling is addressed through adjudication and missing data handling. Controls are the standard care group. Independent replication is not applicable for a single pivotal trial.
“Randomisation was done centrally at the main study centre by using permuted block randomisation (block size of six), implemented through a web based randomisation system”
“Ethics committee and institutional review board restrictions meant that a sham procedure was not permitted and patients could not be blinded to allocation. However, all researchers, clinicians, and staff members responsible for follow-up care, outcome adjudication, and data analysis remained blinded.”
“We initially calculated the sample size to include approximately 118 patients in the intervention arm and 220 patients in the control arm to detect a difference in heart failure incidence rate, assuming rates of 3.9% in the intervention group and 12% in the control group on the basis of the results from the BAMI trial.”
“Randomisation was done centrally at the main study centre by using permuted block randomisation (block size of six), implemented through a web based randomisation system”
“Ethics committee and institutional review board restrictions meant that a sham procedure was not permitted and patients could not be blinded to allocation.”
“We initially calculated the sample size to include approximately 118 patients in the intervention arm and 220 patients in the control arm to detect a difference in heart failure incidence rate, assuming rates of 3.9% in the intervention group and 12% in the control group”
Sex is reported (85% male in intervention, 79% in control). Age is reported with mean and SD. Demographics include age, sex, BMI, and comorbidities. Species/strain and housing are not applicable for a human trial. Sex justification is not applicable because both sexes are enrolled.
“The mean age of participants was similar in the two groups: 57.8 (standard deviation 10.7) years for the intervention group and 59.2 (10.9) years for the control group. Most patients were male: 85% in the intervention group and 79% in the control group.”
“Most patients were male: 85% in the intervention group and 79% in the control group.”
“The mean age of participants was similar in the two groups: 57.8 (standard deviation 10.7) years for the intervention group and 59.2 (10.9) years for the control group.”
“Hypertension | 57 (42) | 117 (45) | 174 (44)”
The study reports approval from a named ethics committee with an approval code (IR.SUMS.REC.1400.409) and states informed consent was obtained from all patients. Regulatory compliance with the Declaration of Helsinki is stated.
“The study protocol received approval from the local institutional review board and ethics committee (approval code: IR.SUMS.REC.1400.409)”
“Informed consent was obtained from all patients.”
“The study protocol received approval from the local institutional review board and ethics committee (approval code: IR.SUMS.REC.1400.409)”
“Informed consent was obtained from all patients.”
“The trial adhered to the principles outlined in the Declaration of Helsinki.”
The MSCs are described with source, characterization (ISCT criteria), and quality control. The cell product is the key resource; antibodies and cell lines are not applicable. Statistical software (Stata 18) is identified.
“We adhered to the minimal criteria established by the International Society for Cell and Gene Therapy (ISCT) to characterise mesenchymal stem cells.”
“We used Stata version 18 for all statistical analysis.”
“Then, flow cytometry analysis showed the expression of surface markers CD105, CD73, and CD90, whereas the cells were negative for CD45, CD34, CD11b, CD31, and HLA-DR, aligning with ISCT standards.”
“We used Stata version 18 for all statistical analysis.”
Tests are named (Cox regression, log-rank, Wilcoxon, etc.). Assumptions are addressed (proportional hazards tested). Exact p-values are reported. Effect sizes with CIs are reported. Software is identified. Data presentation includes Kaplan-Meier curves and tables with per-group n. Mathematical plausibility checks were not fully verifiable but no obvious errors were found.
“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024”
“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89”
“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89; P=0.024”
“hazard ratio 0.43, 95% confidence interval 0.21 to 0.89”
“we evaluated the proportional hazards assumption by using the global test on the basis of scaled Schoenfeld residuals”
The data availability statement provides a concrete route via Figshare with a DOI. Repository deposit is applicable and adequate. Accession numbers are not applicable for this type of data. Code sharing is not applicable as no custom code is mentioned.
“De-identified individual participant data underlying the results reported in this article are available through the Figshare sharing platform ( https://doi.org/10.6084/m9.figshare.29375153.v2 ).”
“De-identified individual participant data underlying the results reported in this article are available through the Figshare sharing platform ( https://doi.org/10.6084/m9.figshare.29375153.v2 ).”
Trial registration is provided (NCT05043610). CONSORT guidelines are mentioned. All outcomes are reported, including non-significant ones. Limitations are discussed. Conclusions are proportional. Funding and COI are declared.
“ClinicalTrials.gov NCT05043610”
“This manuscript has been prepared in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”
“ClinicalTrials.gov NCT05043610”
“This manuscript has been prepared in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”
“The limitations of this study include the inability to do a sham procedure for the control group, which would have allowed for a double blinded study design instead of a single blinded format.”
Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
Broken references and links
None foundReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
Checked — nothing surfaced.
Checked 36 references by DOI: 36 verified.
Every extracted reference resolved against Crossref/OpenAlex with no retraction flags.
1 data/code link checked; 1 live.
- dataFigshareLIVEHTTP 202https://doi.org/10.6084/m9.figshare.29375153.v2Resolves to Figshare (data repository).
Copyediting
5 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 5 minor suggestions below.
5 copyedit issues flagged: mostly consistency, clarity, typo.
- MINORtypoMethods, Patient care“conduced”→ conductedTypographical error.
- MINORconsistencyTable 1“eGFR <60 mm/min/1.73 m 2 | 18 (134) | 39 (1) | 57 (14)”→ Check the numbers; likely a formatting error.The numbers in parentheses appear incorrect (134 and 1).
- MINORclarityDiscussion, Comparison with other studies“8.1% (4.7% to 2.5%; n=15)”→ Check the CI; likely should be 4.7% to 12.5%.The upper bound of the CI is lower than the lower bound.
- MINORconsistencyTable 1“eGFR <60 mm/min/1.73 m 2 | 18 (134) | 39 (1) | 57 (14)”→ Check the numbers in parentheses; likely should be 18 (13) and 39 (15) to match percentages.Percentages appear inconsistent with counts.
- MINORclarityDiscussion, Comparison with other studies“8.1% (4.7% to 2.5%; n=15)”→ Check the confidence interval; likely should be 4.7% to 12.5%.The upper bound of the CI appears to be a typo.
The published work is robust and methodologically sound; an informed reader should weigh the minor reporting inconsistencies (Table 1 percentages, a CI typo) as low-severity issues that do not affect the conclusions. No erratum is strictly required, but correcting these typos would improve clarity. The trial's single-blind design and lack of sham control are acknowledged limitations that readers should consider when interpreting the effect size.
- 1.HIGHcopyeditIn Table 1, correct the eGFR <60 mm/min/1.73 m2 row: the percentages in parentheses (134 and 1) are clearly erroneous; they should likely be 13 and 15 to match the counts (18 and 39) and overall percentage (14).The current numbers are internally inconsistent and would mislead readers about the baseline renal function distribution.
- 2.HIGHcopyeditIn the Discussion (Comparison with other studies), correct the BAMI readmission CI '8.1% (4.7% to 2.5%; n=15)' — the upper bound is lower than the lower bound; it should likely be '4.7% to 12.5%'.An impossible confidence interval is a clear typographical error that undermines the credibility of the comparison.
- 3.MEDIUMcopyeditIn Methods, Patient care, change 'conduced' to 'conducted'.Fixes a typographical error that detracts from manuscript professionalism.
- 4.MEDIUMreportingIn the main text (Methods, Sample size, randomisation, and blinding), add a sentence describing the randomization sequence generation and allocation concealment (currently only in supplementary materials).Enhances transparency and reproducibility, as these are key CONSORT items.
- 5.MEDIUMreportingIn the Results (Baseline characteristics), report the exact number of female participants in each group (not just percentages).The small number of females is a noted limitation; exact counts would allow readers to assess sex-specific analyses.
- 6.MEDIUMdata codeAdd a statement in the Data availability section about the availability of statistical analysis code, even if no custom code was used.Clarifies reproducibility and avoids ambiguity about code sharing.
- 7.MEDIUMreportingIn the Abstract, add a brief note about the single-blind design and lack of sham control as a limitation (currently only in the Discussion).Ensures the abstract accurately reflects the study's limitations for readers who only see the abstract.
- 8.MEDIUMreportingIn the Results, report the exact p-values for the log-rank tests in the text (currently only in figures).Provides precise statistical information for readers who may not access figures.
- 9.MEDIUMreportingIn the Methods or Supplementary, provide the full adjusted models (with all covariates) in the main text rather than only in supplementary materials.Improves transparency of the primary analysis and allows readers to assess confounding control.
- 10.MEDIUMreportingIn Table 1, report the number of patients with missing data for each covariate, as some denominators are less than the group total.Clarifies the extent of missing data and how it was handled.
- 11.LOWreportingAdd a CONSORT checklist as a supplementary file and specify the exact version of CONSORT used.Confirms adherence to reporting guidelines and facilitates reviewer/reader verification.
- 12.LOWdata codeProvide a data dictionary for the Figshare dataset to facilitate reuse.Enhances the usability of the deposited data for independent re-analysis.
- 13.LOWreportingIn the Discussion, add a note about the generalizability of the findings given the specific population (first STEMI, LVEF<40%) and the multi-center setting.Helps readers interpret the applicability of the results to broader patient populations.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.
Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.