NCT04810806

Timing of Coronary Angiography in NSTE-ACS With ADHF

Immediate Versus Delayed Coronary Angiography in Patients With Non-ST-Segment Acute Coronary Syndrome With Acute Decompensated Heart Failure

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesized that immediate coronary angiography (CAG) within 2 hours after admission can reduce mortality compared to delayed CAG after stabilization of acute decompensated heart failure (ADHF) in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) complicated by ADHF. Patients with NSTE-ACS complicated by ADHF will be randomized to immediate CAG (coronary angiography \< 2 hours after randomization) or delayed CAG after stablization group by 1:1 fashion. This study is a prospective, non-blinded, randomized trial.

Detailed description

Study objective In this study, investigators aim to compare early coronary angiography (CAG \< 2 hours after randomization) and delayed CAG after stabilization of acute decompensated heart failure (ADHF) in patients with acute non-ST-elevation acute coronary syndrome (NSTE-ACS) complicated by ADHF. This study is a prospective, non-blinded, randomized trial. Study background An ADHF is frequently encountered in patients with NSTE-ACS. Although its incidence has been decreased during the decades, it is still high up to 8-12% at initial presentation of NSTE-ACS. Patients with NSTE-ACS complicated by ADHF is also known to be associated with worse in-hospital and long-term clinical outcomes than those without heart failure (HF). Because revascularization could reduce mortality in these patients, it should be done in all patients with NSTE-ACS with ADHF. Current guidelines recommend immediate CAG within 2 hours after admission in patients with NSTE-ACS complicated by ADHF. However, it is difficult to decide the timing of coronary angiography in these high risk patients. Notably, the most of randomized trials about the timing of coronary angiography in NSTE-ACS excluded these high risk patients, therefore there is lack of evidence for immediate coronary angiography within 2 hours after admission in patients with NSTE-ACS complicated by ADHF. Investigators will compare immediate CAG within 2 hours after admission and delayed CAG after stabilization of ADHF in patients with NSTE-ACS complicated by ADHF by randomized controlled trial. Study hypothesis Immediate CAG within 2 hours after admission can reduce mortality compared to delayed CAG after stabilization of ADHF in patients with NSTE-ACS complicated by ADHF.

Conditions

• Heart Failure
• Acute Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	Immediate coronary angiography within 2 hours after randomization	After achievement of informed consent in patients with NSTE-ACS complicated by ADHF, patients will be screened and randomized. Patients will be randomized to immediate CAG group or delayed CAG group. Immediate CAG group will receive CAG within 2 hours after randomization. Patients will receive treatment methods according to CAG results: percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or medical therapy only by operators' discretion.
PROCEDURE	Delayed coronary angiography after stabilization of heart failure	After achievement of informed consent in patients with NSTE-ACS complicated by ADHF, patients will be screened and randomized. Patients will be randomized to immediate CAG group or delayed CAG group. Delayed CAG group will receive CAG after stabilization of ADHF; improvement of symptoms and signs of heart failure. Patients will receive treatment methods according to CAG results: percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or medical therapy only by operators' discretion.

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2021-03-23
• Last updated: 2024-03-01

Locations

1 site across 1 country: South Korea