Acute Clinical Outcomes of Hemorrhagic Myocardial Infarction | NCT06110351

Studies
Acute Clinical Outcomes of Hemorrhagic Myocardial Infarction

NCT06110351

Sponsor

Indiana University

Status

Completed

Last Update Posted

Apr 6, 2025Actual

Enrollment

12,000Actual

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

Nov 8, 2023Actual

Primary Completion Date

Dec 15, 2024Actual

Completion Date

Dec 15, 2024Actual

First Submitted Date

Oct 26, 2023

First Submission Date that Met QC Criteria

Oct 26, 2023

First Posted Date

Oct 31, 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 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

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

12,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Prevalence of acute mortality	30-days and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Acute heart failure	Prevalence of acute heart failure	30-days and 6 months
Arrhythmia	Prevalence of acute arrhythmia	30-days and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-85 years of age
Primary PCI
Post-PCI cardiac biomarker labs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Primary PCI STEMI patients having post-PCI biomarkers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IU Methodist Hospital		Indianapolis	Indiana	46202	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