Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 1:41 PM
Study NCT ID:
NCT03159559
Status:
UNKNOWN
Last Update Posted:
2017-05-18
First Post:
2017-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000527', 'term': 'Alprostadil'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}], 'ancestors': [{'id': 'D011458', 'term': 'Prostaglandins E'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myocardial perfusion reserve index (MPRI)', 'timeFrame': '1 week'}]}, 'conditionsModule': {'conditions': ['Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'This study is undertaken to determine if intravenous Lipo-PGE1 therapy would improve coronary microvascular perfusion in patients with ischemic heart disease by CMRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial\n2. Patients aged between 35-70, no limitation on gender\n3. Patients with significant CAD and no need to PCI: 50%-70% luminal stenosis as determined by diagnostic coronary angiography, and left main coronary artery stenosis less than 50%; no history of revascularization procedures before\n4. MPRI\\<2.0\n5. Type 2 DM patients with glycosylated hemoglobin levels\\>7%\n6. All patients were PGE1-naive, defined as receiving no PGE1 therapy for more than 7 days during the previous 12 months\n7. Hypertension remained stable for last 3 months, patients with controlled BP level: SBP\\<160mmHg and DBP\\<95mmHg\n\nExclusion Criteria:\n\n1. Patients with a history of allergic to PGE1 or a history of prior PGE1 treatment.\n2. History of revascularization procedures before: PCI or CABG\n3. Patients with implanted pacemaker or ICD, ventricular assist device and intra-aortic balloon counter pulsation pump\n4. Patients who have experienced myocardial infarction\n5. Patients with serious systolic left ventricular function failure: echocardiography EF\\<25%\n6. Claustrophobia\n7. Patients who used Insulin pumps\n8. SBP\\<90mmHg\n9. Chronic renal function failure: creatinine level \\>2.5mg/dl or 221umol/l\n10. Patients with serious or frequent arrhythmia ,atrial fibrillation、frequent ventricular premature contraction、sick sinus syndrome, second- or third degree atrioventricular block\n11. Prior non-cardiac illness with estimated life expectancy \\<2-yrs\n12. Women who are pregnant, lactation,or maybe pregnant in the study period\n13. Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT03159559', 'briefTitle': 'PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A Randomized, Open-label Single-center Trial of Lipo-prostaglandin E1 Improves Coronary Microcirculation Dysfunction in Patients With Ischemic Heart Disease Combine With Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'TJH-CV-Lipo-PGE1-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'In the treatment group ,patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days ;', 'interventionNames': ['Drug: Lipo-PGE1']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'In the control group, patients received conventional therapy only.'}], 'interventions': [{'name': 'Lipo-PGE1', 'type': 'DRUG', 'otherNames': ['aspirin', 'clopidogrel', 'antidiabetic drugs'], 'description': 'Patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days', 'armGroupLabels': ['Treatment group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of Internal medicine Dept. and Cardiovascular Division', 'investigatorFullName': 'Dao Wen Wang', 'investigatorAffiliation': 'Tongji Hospital'}}}}