Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-03 @ 12:33 AM
Study NCT ID:
NCT01162902
Status:
UNKNOWN
Last Update Posted:
2013-12-17
First Post:
2010-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-15', 'studyFirstSubmitDate': '2010-04-30', 'studyFirstSubmitQcDate': '2010-07-13', 'lastUpdatePostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wall to lumen ratio of fundus vessel', 'timeFrame': 'baseline, 9 months', 'description': 'Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up'}], 'secondaryOutcomes': [{'measure': 'lipid parameter', 'timeFrame': 'baseline, 9 months', 'description': 'Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL'}, {'measure': 'Serum markers of inflammation', 'timeFrame': 'baseline, 9 months', 'description': 'CRP'}, {'measure': 'Change of nitrate need', 'timeFrame': 'baseline, 1 months, and 3 months', 'description': 'Measure of change of nitrate need'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stable Angina']}, 'descriptionModule': {'briefSummary': 'Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI\n* Unstable Angina/NSTEMI patients who completed PCI for main lesions\n* Either systolic \\> 130mmHg or diastolic \\> 80mmHg, or patients with anti-hypertensive drugs\n\nExclusion Criteria:\n\n* STEMI patients within one month\n* Variant Angina\n* Liver function abnormality or renal failure\n* History of Hypersensitivity to testing drugs\n* Severe heart failure(NYHA class\\>3) or uncorrectable hematologic disease\n* Woman possible to be pregnant\n* Uncontrolled diabetes\n* Expected life span \\< one year'}, 'identificationModule': {'nctId': 'NCT01162902', 'briefTitle': 'Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation', 'orgStudyIdInfo': {'id': 'ABC Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diltiazem treated group', 'description': 'Diltiazem 180mg treated group', 'interventionNames': ['Drug: Diltiazem treated group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bisoprolol treated group', 'description': 'Bisoprolol 5mg treated group', 'interventionNames': ['Drug: Bisoprolol treated group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Candesartan treated group', 'description': 'Candesartan 32mg treated group', 'interventionNames': ['Drug: Candesartan treated group']}], 'interventions': [{'name': 'Diltiazem treated group', 'type': 'DRUG', 'description': 'Diltiazem 180mg for 9 months', 'armGroupLabels': ['Diltiazem treated group']}, {'name': 'Bisoprolol treated group', 'type': 'DRUG', 'description': 'Bisoprolol 5mg for 9 months', 'armGroupLabels': ['Bisoprolol treated group']}, {'name': 'Candesartan treated group', 'type': 'DRUG', 'description': 'Candesartan 32mg for 9 months', 'armGroupLabels': ['Candesartan treated group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Hyo-Soo Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hae-Young Lee, MD,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hae-Young Lee, MD, PhD', 'role': 'CONTACT', 'email': 'hylee612@snu.ac.kr', 'phone': '82-10-4528-6160'}, {'name': 'Hyo-Soo Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hyosoo@snu.ac.kr', 'phone': '82-2-2072-2226'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hyo-Soo, Kim', 'oldOrganization': 'Seoul National University Hospital'}}}}