Timing of Coronary Angiography in NSTEMI Complicated by Acute HF
Recruiting · NCT07002164 · Interventional (participants receive a specific treatment) · Lead sponsor: Chonnam National University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
20 locations listed.
- 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