Timing of Coronary Angiography in NSTE-ACS With ADHF

Chonnam National University Hospital316 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Conditions

Heart Failure Acute Coronary Syndrome

Interventions

Immediate coronary angiography within 2 hours after randomizationPROCEDURE

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.

Delayed coronary angiography after stabilization of heart failurePROCEDURE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Chonnam National University Hospital

Gwangju, South Korea

Outcomes

Primary Outcomes

Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia

Time frame: Up to 12 months

Secondary Outcomes

Rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia

All-cause death, non-fatal myocardial infarction or recurrent ischemia during initial hospitalization

Time frame: Up to 12 months

In-hospital mortality

All-cause mortality during initial hospitalization

Time frame: Up to 12 months

In-hospital cardiac mortality

Cardiac mortality during initial hospitalization

Time frame: Up to 12 months

Rate of procedural complications during coronary angiography or percutaneous coronary intervention

Rate of procedural complications during coronary angiography or percutaneous coronary intervention during initial hospitalization

Time frame: Up to 12 months

Peak level of troponin-I

Peak level of troponin-I during initial hospitalization

Time frame: Up to 12 months

Rate of recurrent ischemia

Rate of recurrent ischemia during initial hospitalization

Time frame: Up to 12 months

Rate of Non-fatal myocardial infarction

Data from ClinicalTrials.gov

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