Human study PLS-00125

Relation of Left Ventricular Mass and Infarct Size in Anterior Wall ST-Segment Elevation Acute Myocardial Infarction (from the EMBRACE STEMI Clinical Trial).

Randomized controlled trial · 300 participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Only the abstract was available. Essential methods may be missing, which limits what can be judged.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

Relation of Left Ventricular Mass and Infarct Size in Anterior Wall ST-Segment Elevation Acute Myocardial Infarction (from the EMBRACE STEMI Clinical Trial).primary · The American journal of cardiology · 2016-06-15 · PMID 27392509 · DOI
Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Eventsregistry entry · NCT01572909 (COMPLETED, results posted, planned enrollment 300)

Design and participants

Design: Randomized controlled trial
Population: Patients with a first anterior ST-segment elevation myocardial infarction, an occluded left anterior descending artery and an available LV mass measurement in the EMBRACE STEMI trial (n = 100 in this post hoc analysis).
Conditions: Anterior wall ST-segment elevation myocardial infarction, Reperfusion injury
Planned enrollment (registry): Not reported
Enrolled: 300
Randomized: Not reported
Completed follow-up: Not reported
Funding: PubMed publication type lists non-US government research support; the funder is not named in the record.

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

Elamipretide (Bendavia/MTP-131) (intervention) · elamipretide · Elamipretide, also named Bendavia and MTP-131 in the registry · Not reported assigned
Placebo (comparator) · placebo · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

CK-MB area under the curve (biomarker infarct size)

post hoc outcome · surrogate · First 72 hours · Area under the curve of creatine kinase-MB release, core laboratory

—: other, p = 0.02 — In pooled patients, LV mass was independently associated with CK-MB AUC in the multivariate model and accounted for 58% of predicted variance.

Troponin I area under the curve (biomarker infarct size)

post hoc outcome · surrogate · First 72 hours · Area under the curve of troponin I release, core laboratory

—: other, p = 0.03 — In pooled patients, LV mass was independently associated with TnI AUC in the multivariate model and accounted for 47% of predicted variance.

Myocardial salvage index

post hoc outcome · surrogate · Day 4 · Myocardial salvage index assessed by core laboratory with cardiac magnetic resonance

—: other, p = 0.003 — In pooled patients, LV mass was independently associated with MSI in the multivariate model and accounted for 60% of predicted variance.

Adverse events

None reported. That is not evidence of safety, and how safety was monitored isn’t described.

The authors concluded (paraphrased): The authors concluded that LV mass explains roughly half of the predicted variance in biomarker measures of infarct size and should be considered as an adjustment variable in infarct size studies.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

other: Post hoc pooled analysis of LV mass versus infarct size; it reports no elamipretide versus placebo comparison, so it gives no information on the compound's effect.
inappropriate endpoint: All outcomes are surrogates: CK-MB AUC, troponin I AUC and the CMR myocardial salvage index. No clinical events are reported.
selection bias: Only 100 of 300 enrolled patients were analyzed: those with anterior STEMI, an occluded LAD and an available LV mass measurement.
confounding: The association between LV mass and infarct size is observational within the trial and is adjusted only for listed covariates.
abstract only: Only the abstract and registry fields are available. Arm sizes, safety data and funding details are not reported.
funding or conflicts: Funding and conflicts of interest are not stated in the record.

CK-MB area under the curve (biomarker infarct size): High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	High risk of bias	The reported result is a pooled association of LV mass with CK-MB AUC, not a randomized comparison, so randomization does not protect it.
Deviations from intended interventions	Some concerns	The abstract gives no information on adherence or deviations from assigned treatment in the parent trial.
Missing outcome data	High risk of bias	Only 100 of 300 enrolled patients had LV mass and anatomy criteria; the exclusions may be informative.
Measurement of the outcome	Some concerns	Biomarkers were measured by a core laboratory, but the abstract does not report blinding.
Selection of the reported result	High risk of bias	This is a post hoc analysis with dominance analysis and no prespecified analysis plan stated in the abstract.

This is a post hoc non-randomized association analysis restricted to a subset, and several domains are at high risk.

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Troponin I area under the curve (biomarker infarct size): High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	High risk of bias	The reported result is a pooled association of LV mass with TnI AUC, not a randomized comparison between arms.
Deviations from intended interventions	Some concerns	The abstract gives no information on adherence or deviations from assigned treatment in the parent trial.
Missing outcome data	High risk of bias	Only 100 of 300 enrolled patients were included, based on available LV mass and lesion criteria.
Measurement of the outcome	Some concerns	Troponin I was measured by a core laboratory, but the abstract does not report blinding.
Selection of the reported result	High risk of bias	This is a post hoc analysis and no prespecified plan is described in the abstract.

This is a post hoc pooled association in a selected subset, with several high-risk domains.

Myocardial salvage index: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	High risk of bias	The reported result is a pooled association of LV mass with MSI, not a randomized treatment comparison.
Deviations from intended interventions	Some concerns	The abstract gives no information on adherence or deviations from assigned treatment in the parent trial.
Missing outcome data	High risk of bias	Only 100 of 300 enrolled patients with available day 4 CMR LV mass were analyzed.
Measurement of the outcome	Some concerns	CMR was read by a core laboratory, but the abstract does not state whether readers were blinded.
Selection of the reported result	High risk of bias	This is a post hoc analysis and no prespecified analysis plan is reported in the abstract.

This is a post hoc pooled association in a selected subset, with several high-risk domains.

Claims this study informs

Improves function in Barth syndrome: not eligible (wrong population) for “Muscle strength, exercise capacity and fatigue”
Improves exercise capacity in primary mitochondrial myopathy: not eligible (wrong population) for “Six-minute walk distance and fatigue”
Is safe for human administration: not eligible (insufficient data) for “Adverse events, including injection-site reactions, and discontinuations”

Where each value comes from

arms: NCT NCT01572909, registry (interventions) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 27392509, abstract (sentences 9-10) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 27392509, abstract (sentence 3) · extracted by AI (automated, not verified by a person) · abstract only
funding: PMID 27392509, title (publication types) · extracted by AI (automated, not verified by a person) · abstract only
limitations: PMID 27392509, abstract (sentences 3-4) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 27392509, abstract (sentences 3 and 5) · extracted by AI (automated, not verified by a person) · abstract only
participants: NCT NCT01572909, registry (enrollment) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 27392509, abstract (sentence 4) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 27392509, abstract (sentences 7-8) · extracted by AI (automated, not verified by a person) · abstract only

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).