Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-06 @ 9:13 PM
Study NCT ID:
NCT03206593
Status:
UNKNOWN
Last Update Posted:
2017-07-02
First Post:
2017-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-29', 'studyFirstSubmitDate': '2017-06-29', 'studyFirstSubmitQcDate': '2017-06-29', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular diseases outcomes', 'timeFrame': '12 months after discharge from index hospitalization', 'description': 'Fatal or non-fatal myocardial infarction, fatal or non-fatal ischemic stroke, re-hospitalization due to heart failure, revascularization by percutaneous coronary intervention or coronary artery bypass grafting, and cardiovascular mortality'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '12 months after discharge from index hospitalization', 'description': 'All-cause mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Heart Failure', 'Lipids', 'Fasting Plasma Glucose', 'Cardiovascular Outcomes', 'All-cause Mortality']}, 'descriptionModule': {'briefSummary': 'Current prospective cohort study is to evaluate the association between fasting lipid profiles (including total cholesterol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, triglycerides, apolipoprotein A, apolipoprotein B and lipoprotein(a)) and fasting plasma glucose at admission with cardiovascular disease outcomes (including fatal and non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, re-hospitalization due to heart failure, revascularization by percutaneous coronary intervention or coronary artery bypass grafting, or cardiovascular mortality) and all-cause mortality.in patients with ischemic heart failure and left ventricular ejection fraction \\< 45 % evaluated by echocardiography during 12 months follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who are diagnosed as coronary artery disease by coronary angiography and also have left ventricular ejection fraction \\< 45% enroll if qualified to our inclusion criteria and exclusion criteria and informed consent will be provided.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: 1.Diagnosed as coronary artery disease by coronary angiography; 2. Left ventricular ejection fraction \\< 45% evaluated by echocardiography during index hospitalization.\n\n\\-\n\nExclusion Criteria: Coexistent malignant diseases; stage 3 or more of chronic kidney disease; liver dysfunction with ALT or AST higher than 3 times of normal limit range; do not want to participant in current study\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03206593', 'briefTitle': 'Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Fasting Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure', 'orgStudyIdInfo': {'id': 'No.GDREC2017128H(R1)'}}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Anping Cai, M.D.', 'role': 'CONTACT', 'email': 'caianping1983@hotmail.com', 'phone': '860215989267312'}], 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Faye Jiang', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}