Clinical trial NCT04810806: Timing of Coronary Angiography in NSTE-ACS With ADHF
Official title: Immediate Versus Delayed Coronary Angiography in Patients With Non-ST-Segment Acute Coronary Syndrome With Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Acute Coronary Syndrome
Keywords: Heart Failure
Acute Coronary Syndrome
Non-ST-Segment Elevation Acute Coronary Syndrome
Myocardial Infarction
Coronary Disease
Cardiovascular Diseases
Heart Diseases
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 316
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
timeFrame: Up to 12 months
Secondary outcomes:
measure: Rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
timeFrame: Up to 12 months
measure: In-hospital mortality
timeFrame: Up to 12 months
measure: In-hospital cardiac mortality
timeFrame: Up to 12 months
measure: Rate of procedural complications during coronary angiography or percutaneous coronary intervention
timeFrame: Up to 12 months
measure: Peak level of troponin-I
timeFrame: Up to 12 months
measure: Rate of recurrent ischemia
timeFrame: Up to 12 months
measure: Rate of Non-fatal myocardial infarction
timeFrame: Up to 12 months
measure: Rate of stroke
timeFrame: Up to 12 months
measure: Usage rate of non-invasive positive pressure ventilation
timeFrame: Up to 12 months
measure: Usage rate of mechanical ventilator
timeFrame: Up to 12 months
measure: Usage rate of renal replacement therapy
timeFrame: Up to 12 months
measure: Usage rate of mechanical circulatory support
timeFrame: Up to 12 months
measure: Rate of acute kidney injury
timeFrame: Up to 12 months
measure: Rate of stent thrombosis
timeFrame: Up to 12 months
measure: Rate of major bleeding
timeFrame: Up to 12 months
measure: Duration of initial hospitalization
timeFrame: Up to 12 months
measure: Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia
timeFrame: Up to 1 month
measure: Cumulative incidence rate of all-cause death
timeFrame: Up to 1 month
measure: Cumulative incidence rate of cardiac death
timeFrame: Up to 1 month
measure: Cumulative incidence rate of rehospitalization due to heart failure
timeFrame: Up to 1 month
measure: Cumulative incidence rate of cardiogenic shock
timeFrame: Up to 1 month
measure: Cumulative incidence rate of stroke
timeFrame: Up to 1 month
measure: Cumulative incidence rate of stent thrombosis
timeFrame: Up to 1 month
measure: Cumulative incidence rate of major bleeding (BARC classification 3-5)
timeFrame: Up to 1 month
measure: Cumulative incidence rate of recurrent ischemia
timeFrame: Up to 1 month
measure: Cumulative incidence rate of non-fatal myocardial infarction
timeFrame: Up to 1 month
measure: Cumulative incidence rate of all unplanned revascularization
timeFrame: Up to 1 month
measure: Cumulative incidence rate of all-cause death
timeFrame: Up to 12 months
measure: Cumulative incidence rate of cardiac death
timeFrame: Up to 12 months
measure: Cumulative incidence rate of rehospitalization due to heart failure
timeFrame: Up to 12 months
measure: Cumulative incidence rate of cardiogenic shock
timeFrame: Up to 12 months
measure: Cumulative incidence rate of stroke
timeFrame: Up to 12 months
measure: Cumulative incidence rate of stent thrombosis
timeFrame: Up to 12 months
measure: Cumulative incidence rate of major bleeding (BARC classification 3-5)
timeFrame: Up to 12 months
measure: Cumulative incidence rate of recurrent ischemia
timeFrame: Up to 12 months
measure: Cumulative incidence rate of non-fatal myocardial infarction
timeFrame: Up to 12 months
measure: Cumulative incidence rate of all unplanned revascularization
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Min Chul Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: