NCT05898425

Brief Summary

This study examines the relationship between angiographic coronary collaterals (Rentrop grades) and post-reperfusion microvascular injury. This study aims to assess the impact of coronary collateral circulation on intramyocardial hemorrhage incidence and extent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

August 8, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2024

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

2.1 years

First QC Date

June 1, 2023

Last Update Submit

April 4, 2025

Conditions

Acute Myocardial Infarction

Keywords

Coronary AngiographyIntramyocardial HemorrhageCardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (2)

  • Incidence of Intramyocardial hemorrhage (IMH)

    Collaterals grades (0-III) will be correlated with incidence rate of IMH

    Day 3

  • Volume of Intramyocardial hemorrhage (IMH)

    Collaterals grades (0-III) will be correlated with IMH volume

    Day 3

Eligibility Criteria

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

The study population comprises individuals aged 18 years or older who are diagnosed with Index STEMI, based on ACC/AHA criteria, and have completed coronary angiogram with PCI and CMR.

1. Age 18-85 years 2. Index STEMI 3. Coronary angiogram with Primary coronary intervention 4. No contraindications for Cardiac MRI

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

IU Methodist Hospital

Indianapolis, Indiana, 46032, United States

Location

Study Officials

  • Rohan Dharmakumar, PhD

    Indiana University School of Medicine

    STUDY DIRECTOR

  • Keyur P Vora, MD FACC

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, Krannert Cardiovascular Research Center, Indiana University School of Medicine

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 12, 2023

Study Start

August 8, 2022

Primary Completion

August 31, 2024

Study Completion

September 17, 2024

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)