Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8)

12 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 16 tests: 16 consistent, 0 inconsistent, 16 via agent-written checks.

4 integrity concerns flagged (0 high).

16 copyedit issues flagged: mostly typo, consistency, punctuation.

Checked 36 references: 36 verified.

4 data/code links checked; 4 live.

Ready after minor-to-moderate edits. The most consequential gaps are in key resources (missing identifiers and mycoplasma testing) and the statistical discrepancy in Table 2. Addressing these, along with the copyedit fixes, will bring the manuscript to a submission-ready state.

1. 1.
   HIGHrigor

   Add vendor, catalog number, clone, and RRID for all antibodies used in flow cytometry (CD105, CD73, CD90, CD45, CD34, CD11b, CD31, HLA-DR) to the Methods section.

   Antibody identification is essential for reproducibility; missing these details is a key resource gap.
2. 2.
   HIGHrigor

   Explicitly report mycoplasma testing (method and result) for each batch of mesenchymal stem cells in the Methods section.

   Mycoplasma contamination is a known issue in cell therapy; its absence is a key resource gap.
3. 3.
   HIGHrigor

   Provide a standard identifier (e.g., cell bank accession number, RRID) for the Wharton's jelly-derived mesenchymal stem cell product to improve traceability.

   A unique identifier for the cell product is essential for reproducibility and regulatory compliance.
4. 4.
   HIGHstatistics

   Correct or clarify the annual incidence rate for heart failure in the control group (Table 2: 37 events/551.88 person-years gives 6.71, not 6.48).

   This discrepancy suggests a possible transcription error that could affect the reported effect size.
5. 5.
   HIGHreporting

   Include the significance level (alpha) and desired power in the sample size calculation description to make the power analysis fully adequate.

   A complete power analysis is a standard requirement for clinical trial reporting.
6. 6.
   HIGHreporting

   Provide a scientific justification for the predominance of male participants in the study, or acknowledge the lack of female representation as a limitation with an explanation of why it occurred.

   Sex imbalance without justification is a biological variable reporting gap.
7. 7.
   HIGHreporting

   Report race/ethnicity data for the study population, or state why it was not collected.

   Race/ethnicity is important for generalizability and is a standard demographic variable.
8. 8.
   HIGHstatistics

   Report the results of normality tests (Shapiro-Wilk/Kruskal-Wallis) in a supplementary table, and describe the explicit action taken when assumptions were violated.

   Assumption verification is incomplete without reporting the test results and subsequent actions.
9. 9.
   HIGHstatistics

   Report exact p-values (e.g., P=0.100 instead of P=0.10) for all outcomes, including non-significant ones.

   Threshold p-values are less informative and can obscure the strength of evidence.
10. 10.
    HIGHcopyedit

    Fix the apparent transcription errors in Table 1: '18 (134)' for eGFR <60 in intervention group should likely be '18 (13)'; '39 (1)' for control should likely be '39 (15)'.

    These percentages are nonsensical and will be flagged by any careful reader or reviewer.
11. 11.
    HIGHcopyedit

    Correct the unit for eGFR from 'mm/min/1.73 m2' to 'mL/min/1.73 m2' in Table 1.

    The standard unit is mL/min/1.73 m2, not mm/min.
12. 12.
    HIGHcopyedit

    Fix missing closing parentheses in Table 2 for cumulative probability values in the control column (e.g., '16.08 (10.90 to 21.27' should be '16.08 (10.90 to 21.27)').

    Missing parentheses are formatting errors that reduce readability.
13. 13.
    MEDIUMreporting

    Add a statement on outlier handling in the statistical analysis section, specifying any pre-specified rules for excluding data points.

    Outlier handling is a standard element of statistical analysis reporting.
14. 14.
    MEDIUMreporting

    In the Discussion, explicitly mention that the study was not powered to detect subgroup effects (relevant for the sex interaction discussion).

    This caveat is important for interpreting subgroup analyses.
15. 15.
    LOWreporting

    Consider providing a CONSORT flow diagram with exact reasons for each exclusion (already included in Figure 1, but ensure numbers sum correctly).

    A complete CONSORT flow diagram is a standard requirement for RCT reporting.