Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
316 participants
INTERVENTIONAL
2021-04-01
2024-03-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate coronary angiography group
Immediate coronary angiography group will routinely receive coronary angiography within 2 hours after randomization.
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.
Delayed coronary angiography group
Delayed coronary angiography group will receive coronary angiography during hospitalization after stabilization of symptoms and signs of heart failure.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
\* 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
19 Years
ALL
No
Sponsors
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Chonnam National University Hospital
OTHER
Responsible Party
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Min Chul Kim
Associate Professor
Principal Investigators
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Min Chul Kim, Professor
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Locations
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Chonnam National University Hospital
Gwangju, , South Korea
Countries
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References
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Lim Y, Park S, Joo D, Lee YK, Oh S, Lee SH, Ahn JH, Hyun DY, Cho KH, Sim DS, Hong YJ, Kim JH, Ahn Y, Kim MC. Immediate versus delayed coronary angiography in patients with non-ST segment elevation acute coronary syndrome complicated with acute decompensated heart failure: The EARLY-HF randomized clinical trial. Cardiovasc Revasc Med. 2025 Oct 6:S1553-8389(25)00509-3. doi: 10.1016/j.carrev.2025.09.016. Online ahead of print.
Other Identifiers
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CNUH-2020-396
Identifier Type: -
Identifier Source: org_study_id
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