Timing of Coronary Angiography in NSTEMI Complicated by Acute HF

NCT ID: NCT07002164

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2032-04-30

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.

Detailed Description

Acute decompensated heart failure (AHF) is frequently encountered in patients with non-ST-segment elevation myocardial infarction (NSTEMI), and it is known to be associated with worse clinical outcomes that those without heart failure (HF). Although current guidelines recommend immediate invasive strategy for patients with NSTEMI complicated by AHF, its evidence is lack. It is difficult to decide whether to perform early coronary angiography (CAG) according to the guidelines in these high-risk patients due to the risk of procedural complications. Furthermore, the most of randomized trials regarding the timing of CAG in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) have excluded these patients, therefore, there is lack of evidence for performing immediate CAG in such cases. In clinical practice, many patients with NSTEMI complicated by AHF did not receive early CAG. There are only two observational studies which investigated this issue. In the Korean nationwide registry data, a total of 1,027 patients with NSTEMI complicated by AHF were analyzed, and 14.5% among study population underwent early CAG within 2 hours according to the guidelines. All-cause mortality at 12 months was not significantly different irrespective of CAG timing. In other single-center study, early CAG <24 hours was associated with a lower risk of adverse cardiac outcomes compared with delayed CAG ≥24 hours after admission.

Several studies have demonstrated improved clinical outcomes in high-risk patients with NSTE-ACS undergoing early CAG, whereas others have found no significant differences in clinical outcomes. Randomized clinical trials, such as SISCA, ISAR-COOL, RIDDLE-NSTEMI and EARLY, have demonstrated the advantages of early CAG compared to delayed invasive approach (i.e. CAG after stabilization) in high-risk patients with NSTE-ACS. The other trials regarding this issue have failed to show the superiority of early CAG over delayed invasive approach. 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.

Conditions

Myocardial Infarction (MI); Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Immediate coronary angiography

Intervention Type: PROCEDURE

Immediate coronary angiography ≤2 hours after randomization

Delayed coronary angiography after stabilization of acute decompensated heart failure

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

Group Type: ACTIVE_COMPARATOR

Delayed coronary angiography

Intervention Type: PROCEDURE

Delayed coronary angiography after stabilization

Interventions

Immediate coronary angiography

Immediate coronary angiography ≤2 hours after randomization

Intervention Type: PROCEDURE

Delayed coronary angiography

Delayed coronary angiography after stabilization

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chonnam National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Min Chul Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gyeongsang National University Changwon Hospital

Changwon, , South Korea

Keimyung University Dongsan Hospital

Daegu, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Yeongnam University Medical Center

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Gwangju Veterans Hospital

Gwangju, , South Korea

Kwangju Christian Hospital

Gwangju, , South Korea

Jeonbuk National University Hospital

Jeonju, , South Korea

Gyeongsang National University Hospital

Jinju, , South Korea

Dong-A University Hospital

Pusan, , South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

Asan Medical Center

Seoul, , South Korea

Kangbuk Samsung Medical Center

Seoul, , South Korea

Koera University Guro Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

St. Carollo General Hospital

Suncheon, , South Korea

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, , South Korea

Countries

South Korea

Central Contacts

Youngkeun Ahn, Professor

Role: CONTACT

cecilyk@hanmail.net

82-62-220-4764 ext. 82-62-220-4764

Min Chul Kim, Professor

Role: CONTACT

kmc3242@hanmail.net

82-62-220-6578 ext. 82-62-220-6578

Other Identifiers

CNUH-2025-100

Identifier Type: -

Identifier Source: org_study_id