Timing of Coronary Angiography in NSTEMI Complicated by Acute HF

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.

Eligibility

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

Conditions3

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