NCT07002164

Brief Summary

Study objectives: To determine the optimal timing of coronary angiography (CAG) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) complicated by acute decompensated heart failure (AHF). The primary objective of this trial is to test the hypothesis that immediate CAG ≤2 hours after establishment of NSTEMI diagnosis would result in a significant reduction in primary composite outcome of death from any cause, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF) at 12 months after randomization as compared with delayed CAG after stabilization. Study hypothesis: Immediate CAG ≤2 hours after establishment of NSTEMI diagnosis would result in a significant reduction in primary composite outcome of death from any cause, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF) at 12 months after randomization as compared with delayed CAG after stabilization. Background: Although current guidelines recommend early CAG within 2 hours for patients with NSTEMI complicated by AHF, many patients with NSTEMI complicated by AHF did not receive early CAG. However, no randomized clinical trials have evaluated the optimal timing of CAG in patients with NSTEMI complicated by AHF. Therefore, the investigators aimed to perform a prospective, investigator-initiated, open-label, muilticenter trial to compare the efficacy and safety between immediate CAG (CAG \<2 hours after establishment of NSTEMI diagnosis) and delayed CAG after stabilization (i.e. improved dyspnea and disappearance of pulmonary congestion) in participants with NSTEMI complicated by AHF. Study procedure: Following the establishment of NSTEMI diagnosis, participants fulfilling the eligibility criteria will be randomized at a ratio of 1:1 to immediate CAG ≤2 hours after randomization or delayed CAG after stabilization on another day during hospitalization.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
780

participants targeted

Target at P75+ for not_applicable

Timeline
73mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

20 active sites

Status
recruiting

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 Progress12%
Jul 2025Apr 2032

First Submitted

Initial submission to the registry

May 17, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2032

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

May 17, 2025

Last Update Submit

March 17, 2026

Conditions

Keywords

Non-ST-segment elevation myocardial infarctionAcute decompensated heart failureCoronary angiographyTiming

Outcome Measures

Primary Outcomes (1)

  • A cumulative incidence rate of all-cause death, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF)

    1 year

Secondary Outcomes (13)

  • A cumulative incidence rate of all-cause death, non-fatal MI, or hospitalization for HF

    1, 6, 24, 36 months

  • All-cause death

    1, 6, 12, 24, 36 months

  • Non-fatal MI

    1, 6, 12, 24, 36 months

  • Hospitalization for HF

    1, 6, 12, 24, 36 months

  • Cardiovascular death

    1, 6, 12, 24, 36 months

  • +8 more secondary outcomes

Study Arms (2)

Immediate coronary angiography within 2 hours after diagnosis of non-ST-segment elevation myocardial

EXPERIMENTAL

Coronary angiography will be performed within 2 hours after diagnosis of non-ST-segment elevation myocardial infarction.

Procedure: Immediate coronary angiography

Delayed coronary angiography after stabilization of acute decompensated heart failure

ACTIVE COMPARATOR

Coronary angiography will be performed after disappearance of symptoms and signs of acute decompensated heart failure.

Procedure: Delayed coronary angiography

Interventions

Immediate coronary angiography ≤2 hours after randomization

Immediate coronary angiography within 2 hours after diagnosis of non-ST-segment elevation myocardial

Delayed coronary angiography after stabilization

Delayed coronary angiography after stabilization of acute decompensated heart failure

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥19 years
  • Non-ST-segment elevation myocardial infarction
  • New-onset or worsening of dyspnea (New York Heart Association class ≥2)
  • Pulmonary congestion
  • Patient's or guardian's consent after understanding the study

You may not qualify if:

  • Cardiogenic shock at initial presentation
  • ST-segment elevation myocardial infarction
  • ST-segment elevation ≥0.1 mV in at least 2 contiguous leads, or
  • New onset left bundle branch block
  • Posterior wall myocardial infarction
  • Refractory angina
  • Life threatening ventricular arrhythmias
  • Life expectancy \<1 year
  • Apparently non-ischemic cause of HF
  • Pregnancy and lactation
  • History of coronary artery bypass grafting (CABG), or planned CABG
  • Patient's refusal to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Gyeongsang National University Changwon Hospital

Changwon, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

NOT YET RECRUITING

Yeongnam University Medical Center

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Gwangju Veterans Hospital

Gwangju, South Korea

RECRUITING

Kwangju Christian Hospital

Gwangju, South Korea

NOT YET RECRUITING

Jeonbuk National University Hospital

Jeonju, South Korea

RECRUITING

Gyeongsang National University Hospital

Jinju, South Korea

RECRUITING

Dong-A University Hospital

Pusan, South Korea

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Kangbuk Samsung Medical Center

Seoul, South Korea

WITHDRAWN

Koera University Guro Hospital

Seoul, South Korea

NOT YET RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

NOT YET RECRUITING

St. Carollo General Hospital

Suncheon, South Korea

RECRUITING

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Youngkeun Ahn, Professor

CONTACT

Min Chul Kim, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2025

First Posted

June 3, 2025

Study Start

July 15, 2025

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

April 30, 2032

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations