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

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

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 Overview

• Status: Terminated
• Conditions: Heart Failure; Acute Coronary Syndrome
• Intervention / Treatment: Procedure: Immediate coronary angiography within 2 hours after randomization; Procedure: Delayed coronary angiography after stabilization of heart failure

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.

• Study Type: Interventional
• Enrollment (Actual): 316
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate coronary angiography group; Immediate coronary angiography group will routinely receive coronary angiography within 2 hours after randomization.	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.
Active Comparator: Delayed coronary angiography group; Delayed coronary angiography group will receive coronary angiography during hospitalization after stabilization of symptoms and signs of heart failure.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia	Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 12 months
In-hospital mortality	All-cause mortality during initial hospitalization	Up to 12 months
In-hospital cardiac mortality	Cardiac mortality during initial hospitalization	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	Up to 12 months
Peak level of troponin-I	Peak level of troponin-I during initial hospitalization	Up to 12 months
Rate of recurrent ischemia	Rate of recurrent ischemia during initial hospitalization	Up to 12 months
Rate of Non-fatal myocardial infarction	Non-fatal myocardial infarction during initial hospitalization	Up to 12 months
Rate of stroke	Rate of stroke during initial hospitalization	Up to 12 months
Usage rate of non-invasive positive pressure ventilation	Usage rate of non-invasive positive pressure ventilation during initial hospitalization	Up to 12 months
Usage rate of mechanical ventilator	Usage rate of mechanical ventilator during initial hospitalization	Up to 12 months
Usage rate of renal replacement therapy	Usage rate of renal replacement therapy during initial hospitalization	Up to 12 months
Usage rate of mechanical circulatory support	Usage rate of mechanical circulatory support during initial hospitalization	Up to 12 months
Rate of acute kidney injury	Rate of acute kidney injury during initial hospitalization	Up to 12 months
Rate of stent thrombosis	Rate of stent thrombosis during initial hospitalization	Up to 12 months
Rate of major bleeding	Rate of major bleeding during initial hospitalization (BARC classificiation 3-5)	Up to 12 months
Duration of initial hospitalization	Duration of initial hospitalization (days)	Up to 12 months
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia	Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia	Up to 1 month
Cumulative incidence rate of all-cause death	Cumulative incidence rate of all-cause death	Up to 1 month
Cumulative incidence rate of cardiac death	Cumulative incidence rate of cardiac death	Up to 1 month
Cumulative incidence rate of rehospitalization due to heart failure	Cumulative incidence rate of rehospitalization due to heart failure	Up to 1 month
Cumulative incidence rate of cardiogenic shock	Cumulative incidence rate of cardiogenic shock	Up to 1 month
Cumulative incidence rate of stroke	Cumulative incidence rate of stroke	Up to 1 month
Cumulative incidence rate of stent thrombosis	Cumulative incidence rate of stent thrombosis	Up to 1 month
Cumulative incidence rate of major bleeding (BARC classification 3-5)	Cumulative incidence rate of major bleeding (BARC classification 3-5)	Up to 1 month
Cumulative incidence rate of recurrent ischemia	Cumulative incidence rate of recurrent ischemia	Up to 1 month
Cumulative incidence rate of non-fatal myocardial infarction	Cumulative incidence rate of non-fatal myocardial infarction	Up to 1 month
Cumulative incidence rate of all unplanned revascularization	Cumulative incidence rate of all unplanned revascularization	Up to 1 month
Cumulative incidence rate of all-cause death	Cumulative incidence rate of all-cause death	Up to 12 months
Cumulative incidence rate of cardiac death	Cumulative incidence rate of cardiac death	Up to 12 months
Cumulative incidence rate of rehospitalization due to heart failure	Cumulative incidence rate of rehospitalization due to heart failure	Up to 12 months
Cumulative incidence rate of cardiogenic shock	Cumulative incidence rate of cardiogenic shock	Up to 12 months
Cumulative incidence rate of stroke	Cumulative incidence rate of stroke	Up to 12 months
Cumulative incidence rate of stent thrombosis	Cumulative incidence rate of stent thrombosis	Up to 12 months
Cumulative incidence rate of major bleeding (BARC classification 3-5)	Cumulative incidence rate of major bleeding (BARC classification 3-5)	Up to 12 months
Cumulative incidence rate of recurrent ischemia	Cumulative incidence rate of recurrent ischemia	Up to 12 months
Cumulative incidence rate of non-fatal myocardial infarction	Cumulative incidence rate of non-fatal myocardial infarction	Up to 12 months
Cumulative incidence rate of all unplanned revascularization	Cumulative incidence rate of all unplanned revascularization	Up to 12 months

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Investigators: Principal Investigator: Min Chul Kim, Professor, Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: March 14, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiovascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Heart Diseases; Coronary Disease; Non-ST-Segment Elevation Acute Coronary Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Heart Failure; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: CNUH-2020-396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No