Coronary Collaterals and Post-reperfusion Intramyocardial... | NCT05898425

Studies
Coronary Collaterals and Post-reperfusion Intramyocardial Hemorrhage

NCT05898425

Sponsor

Indiana University

Status

Completed

Last Update Posted

Apr 6, 2025Actual

Enrollment

262Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2022Actual

Primary Completion Date

Aug 31, 2024Actual

Completion Date

Sep 17, 2024Actual

First Submitted Date

Jun 1, 2023

First Submission Date that Met QC Criteria

Jun 1, 2023

First Posted Date

Jun 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2025

Last Update Posted Date

Apr 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rohan Dharmakumar, Executive Director, Krannert Cardiovascular Research Center, Indiana University School of Medicine, Indiana UniversityPrincipal Investigator

Lead Sponsor

Indiana UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

262Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Age 18-85 years
Index STEMI
Coronary angiogram with Primary coronary intervention
No contraindications for Cardiac MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rohan Dharmakumar, PhD	Indiana University	Study Director
Keyur P Vora, MD FACC	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IU Methodist Hospital		Indianapolis	Indiana	46032	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided