Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 3:21 PM
Study NCT ID:
NCT04810806
Status:
TERMINATED
Last Update Posted:
2024-03-01
First Post:
2021-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of Coronary Angiography in NSTE-ACS With ADHF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}}, 'statusModule': {'whyStopped': 'Slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2021-03-14', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia'}], 'secondaryOutcomes': [{'measure': 'Rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia', 'timeFrame': 'Up to 12 months', 'description': 'All-cause death, non-fatal myocardial infarction or recurrent ischemia during initial hospitalization'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Up to 12 months', 'description': 'All-cause mortality during initial hospitalization'}, {'measure': 'In-hospital cardiac mortality', 'timeFrame': 'Up to 12 months', 'description': 'Cardiac mortality during initial hospitalization'}, {'measure': 'Rate of procedural complications during coronary angiography or percutaneous coronary intervention', 'timeFrame': 'Up to 12 months', 'description': 'Rate of procedural complications during coronary angiography or percutaneous coronary intervention during initial hospitalization'}, {'measure': 'Peak level of troponin-I', 'timeFrame': 'Up to 12 months', 'description': 'Peak level of troponin-I during initial hospitalization'}, {'measure': 'Rate of recurrent ischemia', 'timeFrame': 'Up to 12 months', 'description': 'Rate of recurrent ischemia during initial hospitalization'}, {'measure': 'Rate of Non-fatal myocardial infarction', 'timeFrame': 'Up to 12 months', 'description': 'Non-fatal myocardial infarction during initial hospitalization'}, {'measure': 'Rate of stroke', 'timeFrame': 'Up to 12 months', 'description': 'Rate of stroke during initial hospitalization'}, {'measure': 'Usage rate of non-invasive positive pressure ventilation', 'timeFrame': 'Up to 12 months', 'description': 'Usage rate of non-invasive positive pressure ventilation during initial hospitalization'}, {'measure': 'Usage rate of mechanical ventilator', 'timeFrame': 'Up to 12 months', 'description': 'Usage rate of mechanical ventilator during initial hospitalization'}, {'measure': 'Usage rate of renal replacement therapy', 'timeFrame': 'Up to 12 months', 'description': 'Usage rate of renal replacement therapy during initial hospitalization'}, {'measure': 'Usage rate of mechanical circulatory support', 'timeFrame': 'Up to 12 months', 'description': 'Usage rate of mechanical circulatory support during initial hospitalization'}, {'measure': 'Rate of acute kidney injury', 'timeFrame': 'Up to 12 months', 'description': 'Rate of acute kidney injury during initial hospitalization'}, {'measure': 'Rate of stent thrombosis', 'timeFrame': 'Up to 12 months', 'description': 'Rate of stent thrombosis during initial hospitalization'}, {'measure': 'Rate of major bleeding', 'timeFrame': 'Up to 12 months', 'description': 'Rate of major bleeding during initial hospitalization (BARC classificiation 3-5)'}, {'measure': 'Duration of initial hospitalization', 'timeFrame': 'Up to 12 months', 'description': 'Duration of initial hospitalization (days)'}, {'measure': 'Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of all-cause death, non-fatal myocardial infarction or recurrent ischemia'}, {'measure': 'Cumulative incidence rate of all-cause death', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of all-cause death'}, {'measure': 'Cumulative incidence rate of cardiac death', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of cardiac death'}, {'measure': 'Cumulative incidence rate of rehospitalization due to heart failure', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of rehospitalization due to heart failure'}, {'measure': 'Cumulative incidence rate of cardiogenic shock', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of cardiogenic shock'}, {'measure': 'Cumulative incidence rate of stroke', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of stroke'}, {'measure': 'Cumulative incidence rate of stent thrombosis', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of stent thrombosis'}, {'measure': 'Cumulative incidence rate of major bleeding (BARC classification 3-5)', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of major bleeding (BARC classification 3-5)'}, {'measure': 'Cumulative incidence rate of recurrent ischemia', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of recurrent ischemia'}, {'measure': 'Cumulative incidence rate of non-fatal myocardial infarction', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of non-fatal myocardial infarction'}, {'measure': 'Cumulative incidence rate of all unplanned revascularization', 'timeFrame': 'Up to 1 month', 'description': 'Cumulative incidence rate of all unplanned revascularization'}, {'measure': 'Cumulative incidence rate of all-cause death', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of all-cause death'}, {'measure': 'Cumulative incidence rate of cardiac death', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of cardiac death'}, {'measure': 'Cumulative incidence rate of rehospitalization due to heart failure', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of rehospitalization due to heart failure'}, {'measure': 'Cumulative incidence rate of cardiogenic shock', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of cardiogenic shock'}, {'measure': 'Cumulative incidence rate of stroke', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of stroke'}, {'measure': 'Cumulative incidence rate of stent thrombosis', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of stent thrombosis'}, {'measure': 'Cumulative incidence rate of major bleeding (BARC classification 3-5)', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of major bleeding (BARC classification 3-5)'}, {'measure': 'Cumulative incidence rate of recurrent ischemia', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of recurrent ischemia'}, {'measure': 'Cumulative incidence rate of non-fatal myocardial infarction', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of non-fatal myocardial infarction'}, {'measure': 'Cumulative incidence rate of all unplanned revascularization', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative incidence rate of all unplanned revascularization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Acute Coronary Syndrome', 'Non-ST-Segment Elevation Acute Coronary Syndrome', 'Myocardial Infarction', 'Coronary Disease', 'Cardiovascular Diseases', 'Heart Diseases'], 'conditions': ['Heart Failure', 'Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '41073186', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nStudy 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.\n\nNotably, 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.\n\nInvestigators 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.\n\nStudy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age more than 18 years old\n2. NSTE-ACS\\*\n3. Pulmonary congestion or edema on chest X-ray\n\n * The definition of NSTE-ACS\n\nAmong patients with typical angina, dyspnea or chest discomfort without definite non-cardiac causes, at least 1 presentations of angina that suggest a NSTE-ACS:\n\n1. Rest angina, which is usually more than 20 minutes in duration\n2. New onset angina that markedly limits physical activity\n3. Increasing angina that is more frequent, longer in duration, or occurs with less exertion than previous angina\n\nA 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).\n\nExclusion Criteria:\n\n1\\) Cardiogenic shock\\* 2) Heart failure of other causes rather than NSTE-ACS 3) Terminal malignancy 4) Life expentancy \\< 1 year 5) Pregnancy or lactation\n\n\\* The definition of cardiogenic shock All these criteria should be met\n\n1. Systolic blood pressure \\< 90 mmHg for 30 minutes, or needing inotropics or vasopressor to maintain systolic blood pressure \\> or = 90 mmHg\n2. Pulmonary congestion on chest X-ray or increased left ventricular filling pressure by cardiac catheterization\n3. At least one criteria of organ dysfunction - mental obtundation, clammy ski, ogliuria, renal dysfunction, increased level of blood lactate'}, 'identificationModule': {'nctId': 'NCT04810806', 'acronym': 'EARLY-HF', 'briefTitle': 'Timing of Coronary Angiography in NSTE-ACS With ADHF', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'officialTitle': 'Immediate Versus Delayed Coronary Angiography in Patients With Non-ST-Segment Acute Coronary Syndrome With Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'CNUH-2020-396'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate coronary angiography group', 'description': 'Immediate coronary angiography group will routinely receive coronary angiography within 2 hours after randomization.', 'interventionNames': ['Procedure: Immediate coronary angiography within 2 hours after randomization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed coronary angiography group', 'description': 'Delayed coronary angiography group will receive coronary angiography during hospitalization after stabilization of symptoms and signs of heart failure.', 'interventionNames': ['Procedure: Delayed coronary angiography after stabilization of heart failure']}], 'interventions': [{'name': 'Immediate coronary angiography within 2 hours after randomization', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['Immediate coronary angiography group']}, {'name': 'Delayed coronary angiography after stabilization of heart failure', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['Delayed coronary angiography group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}], 'overallOfficials': [{'name': 'Min Chul Kim, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Min Chul Kim', 'investigatorAffiliation': 'Chonnam National University Hospital'}}}}