Prevention of acute myocardial infarction induced heart failure by intracoronary infusion of mesenchymal stem cells: phase 3 randomised clinical trial (PREVENT-TAHA8)
Assessed by RV013 · Clinical Chair in Health Services Research
Assessed on 31 Oct 2025
OverallReviewer's overall integrity assessment, derived from all research questions No concerns
DOI 10.1136/bmj-2024-083382 (opens in new tab)
Resource ripekg:research-integrity-assessment/RIPEA148131811A593CED
5 Research Questions · 2 Evidence Items
Q1.1 — Does the study have an associated retraction?
Rationale: Agree, just published in the BMJ
Q1.2 — Does the study have an associated expression of concern or other relevant post-publication notice?
Rationale: DIsagree now EoC
Q1.3 — Do other studies by the research team highlight causes for concern?
Rationale: Agree
Q2.2 — Are there concerns relating to the timing or absence of study registration?
Rationale: Agree OK, not exact date in September in paper provided.
Supporting Evidence (2)
Clinical Trial RegistrationSource: Clinical trial registry (e.g. ClinicalTrials.gov, ISRCTN)
Registration ID: NCT05043610
Registry: ClinicalTrials.gov
Registry Link: https://clinicaltrials.gov/study/NCT05043610 (opens in new tab)
Registration Date: 06-09-2021
Prospective:Whether the trial was registered before participant recruitment began Yes
Assessment Rationale:How INSPECT-AI determined the prospective registration status by comparing dates Comparison performed at month level. Registration: 2021-09, LLM Recruitment Start: 2021-09. Deemed prospective at month level.
Study Design EvidenceDates and timelines extracted by INSPECT-AI from the publication text
Recruitment Start: 09-2021
Recruitment Start Rationale:INSPECT-AI's reasoning for how it identified the recruitment start date Methods: '...trial is a single blinded, randomised, phase 3 superiority trial conducted from September 2021 to October 2024.' Used start of conducted range as recruitment_start per rule 5; no specific FPI elsewhere.
Recruitment End: N/A
Recruitment End Rationale:INSPECT-AI's reasoning for how it identified the recruitment end date No direct LPI; range end is not used for recruitment_finish.
Study End: 10-2024
Study End Rationale:INSPECT-AI's reasoning for how it identified the study end date Methods: '...trial is a single blinded, randomised, phase 3 superiority trial conducted from September 2021 to October 2024.' Used end of conducted range as study_end_date per rule 5; no specific completion date.
Overall — What is the overall integrity assessment of the study?
Rationale: No concerns with 4 initial checks - 1.1, 1.2, 1.3, 2.2. Assessment carried out on Friday 31st October, but by November 11th there were 44 notices on PubPeer. Is there a way to update with later information? Alison