Timing of Coronary Angiography in NSTE-ACS With ADHF (EARLY-HF)

Chonnam National University

Status: Terminated

Conditions: Acute Coronary Syndrome; Heart Failure

Treatments: Procedure: Immediate coronary angiography within 2 hours after randomization; Procedure: Delayed coronary angiography after stabilization of heart failure

Study type: Interventional

Funder types: Other

Identifiers

NCT04810806

CNUH-2020-396

Details and patient eligibility

About

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.

Full 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.

Enrollment: 316 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age more than 18 years old

2. NSTE-ACS*

3. Pulmonary congestion or edema on chest X-ray

   • The definition of NSTE-ACS

Among patients with typical angina, dyspnea or chest discomfort without definite non-cardiac causes, at least 1 presentations of angina that suggest a NSTE-ACS:

1. Rest angina, which is usually more than 20 minutes in duration
2. New onset angina that markedly limits physical activity
3. Increasing angina that is more frequent, longer in duration, or occurs with less exertion than previous angina

A 12-lead electrocardiogram should have no ST-segment elevation. Cardiac troponin may elevate (non-ST-segment elevation myocardial infarction) or not elevate (unstable angina pectoris).

Exclusion criteria

1. Cardiogenic shock* 2) Heart failure of other causes rather than NSTE-ACS 3) Terminal malignancy 4) Life expentancy < 1 year 5) Pregnancy or lactation

* The definition of cardiogenic shock All these criteria should be met

1. Systolic blood pressure < 90 mmHg for 30 minutes, or needing inotropics or vasopressor to maintain systolic blood pressure > or = 90 mmHg
2. Pulmonary congestion on chest X-ray or increased left ventricular filling pressure by cardiac catheterization
3. At least one criteria of organ dysfunction - mental obtundation, clammy ski, ogliuria, renal dysfunction, increased level of blood lactate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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316 participants in 2 patient groups

Immediate coronary angiography group

Experimental group

Description:

Immediate coronary angiography group will routinely receive coronary angiography within 2 hours after randomization.

Treatment:

Procedure: Immediate coronary angiography within 2 hours after randomization

Delayed coronary angiography group

Active Comparator group

Description:

Delayed coronary angiography group will receive coronary angiography during hospitalization after stabilization of symptoms and signs of heart failure.

Treatment:

Procedure: Delayed coronary angiography after stabilization of heart failure