NCT05872308

Brief Summary

Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

May 14, 2023

Last Update Submit

September 1, 2025

Conditions

Keywords

STEMITroponinIntramyocardial HemorrhageCardiac MRI

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Threshold

    Levels of markers in hemorrhagic infarct vs. non-hemorrhagic infarct

    48 hours

Secondary Outcomes (6)

  • Peak levels of serum troponin-I

    48 hours

  • Area under the curve (AUC) for serum troponin-I

    48 hours

  • Hemorrhagic infarct size

    48 hours

  • Hemorrhagic infarct volume

    48 hours

  • Hemorrhagic infarct microvascular obstruction

    48 hours

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of individuals aged 18 to 80 who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) and are scheduled for emergency percutaneous coronary intervention (PCI).

You may qualify if:

  • Age ≥ 18 years
  • Index STEMI
  • Coronary angiogram with PCI to occur irrespective of the onset of the symptoms.
  • Ability to provide informed consent for themselves

You may not qualify if:

  • History of prior myocardial infarction,
  • Cardiogenic shock,
  • Patients who present with current cardiac arrest
  • Any contraindication to cardiac CMR (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium),
  • Presence of permanent atrial fibrillation,
  • Unconscious patient,
  • Severe renal insufficiency (creatinine clearance ≤ 30 ml/min/m2 or renal replacement therapy),
  • Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IU Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Synergy Cardiovascular Research Center, Synergy Superspecialty Hospital

Rajkot, Gujarat, India

Location

Related Publications (1)

  • Vora KP, Kalra A, Shah CD, Bhatt K, Kumar A, Pandya T, Poptani V, Chan SF, Singh D, Jambunathan N, Subramanian R, Youssef K, Kanakasabai S, Finney R, Desai A, Kreutz RP, Kovacs RJ, Raman SV, Bhatt DL, Dharmakumar R. In-Hospital Mortality in Hemorrhagic Myocardial Infarction. NEJM Evid. 2025 Sep;4(9):EVIDoa2400294. doi: 10.1056/EVIDoa2400294. Epub 2025 Aug 26.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Keyur P Vora, MD FACC

    Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Chair of Research, Medical Imaging Research Institute

Study Record Dates

First Submitted

May 14, 2023

First Posted

May 24, 2023

Study Start

July 8, 2022

Primary Completion

January 21, 2025

Study Completion

January 21, 2025

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations