Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-06-26 @ 4:59 AM
Study NCT ID:
NCT04245605
Status:
COMPLETED
Last Update Posted:
2022-08-29
First Post:
2020-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Invasive Coronary Angiography Early in Ischemic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2994}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-26', 'studyFirstSubmitDate': '2020-01-27', 'studyFirstSubmitQcDate': '2020-01-27', 'lastUpdatePostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '2 years', 'description': 'Death from any cause after 14 days in landmark analysis'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '2 years', 'description': 'Death due to cardiovascular causes after 14 days in landmark analysis'}], 'secondaryOutcomes': [{'measure': 'All-cause hospital readmission', 'timeFrame': '2 years', 'description': 'Readmissions for all causes after 14 days or hospital discharge in landmark analysis'}, {'measure': 'Heart failure readmission', 'timeFrame': '2 years', 'description': 'Readmissions for heart failure after 14 days or hospital discharge in landmark analysis'}, {'measure': 'Readmission for myocardial infarction', 'timeFrame': '2 years', 'description': 'Readmissions for myocardial infarction after 14 days or hospital discharge in landmark analysis'}, {'measure': 'Rates of revascularization', 'timeFrame': '90 days', 'description': 'Coronary revascularization with CABG surgery or PCI procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary angiography', 'Invasive strategy', 'Myocardial infarction', 'Troponin', 'Heart failure'], 'conditions': ['Acute Heart Failure']}, 'descriptionModule': {'briefSummary': 'To compare the outcomes of patients with acute heart failure who undergo early coronary angiography vs. usual care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients in Ontario, Canada with acute heart failure', 'genderDescription': 'Self-described male or female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Adult patients with acute heart failure, hospitalized in Ontario, Canada, with evidence of possible ischemic heart disease, defined as at least one of: a) prior myocardial infarction, b) troponin elevation, or c) angina.\n\nExclusion Criteria:\n\n* Recent myocardial infarction\n* Coronary angiogram or revascularization within previous 3 months before admission\n* Nonresidents of Ontario, invalid health card number\n* HF diagnosed after admission\n* Admission BNP or NT-proBNP not diagnostic of HF\n* Died within 14 days of admission\n* Palliative within 6 months prior to hospital admission\n* Elevated creatinine concentration\n* Documented anaphylactic contrast allergy\n* Ischemic or hemorrhagic stroke within 3 months prior to admission\n* Highest category of Hospital Frailty Risk Score\n* Active severe bleeding at time of hospital admission\n* Absolute platelet count \\< 20\n* Metastatic cancer'}, 'identificationModule': {'nctId': 'NCT04245605', 'acronym': 'ICE-HF', 'briefTitle': 'Invasive Coronary Angiography Early in Ischemic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Institute for Clinical Evaluative Sciences'}, 'officialTitle': 'Invasive Coronary Angiography Early in Ischemic Heart Failure (ICE-HF)', 'orgStudyIdInfo': {'id': '3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early angiography', 'description': 'Patients admitted to hospital with acute heart failure undergoing coronary angiography within 14 days of hospital admission', 'interventionNames': ['Procedure: Coronary angiography']}, {'label': 'Control', 'description': 'Patients admitted to hospital with acute heart failure not undergoing coronary angiography within 14 days'}], 'interventions': [{'name': 'Coronary angiography', 'type': 'PROCEDURE', 'otherNames': ['Diagnostic coronary angiography'], 'description': 'Coronary angiogram performed either in hospital or post-discharge, within 14 days after initial hospital presentation with heart failure', 'armGroupLabels': ['Early angiography']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Douglas Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICES'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Clinical Evaluative Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Douglas Lee', 'investigatorAffiliation': 'Institute for Clinical Evaluative Sciences'}}}}