Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-12 @ 1:30 PM
Study NCT ID:
NCT03504202
Status:
UNKNOWN
Last Update Posted:
2018-10-25
First Post:
2018-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014292', 'term': 'Trimetazidine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-24', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary flow reserve (CFR) improves', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'Seattle angina score or Canadian angina grade drops', 'timeFrame': 'six months'}, {'measure': 'Six-minute walking experiment improves', 'timeFrame': 'six months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction']}, 'descriptionModule': {'briefSummary': 'This is a prospective study which aims to explore the effect of Trimetazidine on the improvement of coronary microvascular dysfunction in patients with INOCA (ischemia and no obstructive coronary artery disease). Enrolled patients will be assessed SAQ(Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR(coronary flow reserve) .CFR inspection with D-SPECT and pressure guide wire.Patients will receive six months Trimetazidine(35mg tid) after enrollment. And their SAQ (Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR will be followed up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ageā„18 years\n* Typical angina symptoms\n* Coronary angiography or coronary computed tomography examination showed no significant epicardial coronary artery stenosis (\\<20%)\n* Never used trimetazidine\n* The CFR measured by the pressure guide wire is less than 2.0\n* agree to participant the study and sign informed written consent\n* available for six months follow up\n\nExclusion Criteria:\n\n* Severe liver and kidney disease\n* Contraindications of Trimetazidine\n* Use of CYP3A inhibitors, such as diltiazem, verapamil, and other drugs that may affect CFR measurements\n* QT interval extension\n* Atrial fibrillation or left bundle branch block\n* Left ventricular systolic dysfunction (EF \\<55%)\n* Coronary artery fistula\n* Myocardial bridge\n* Non-cardiogenic chest pain and other heart diseases\n* Severe heart valve disease\n* Diabetes\n* Recent ACS( Acute coronary syndrome)\n* Pregnancy\n* Failed to complete inspection'}, 'identificationModule': {'nctId': 'NCT03504202', 'acronym': 'T-MICRO', 'briefTitle': 'Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)', 'orgStudyIdInfo': {'id': 'T-MICRO01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trimetazidine', 'interventionNames': ['Drug: Trimetazidine']}], 'interventions': [{'name': 'Trimetazidine', 'type': 'DRUG', 'description': 'After enrollment, experimental group will receive Trimetazidine(35mg tid) for six months .', 'armGroupLabels': ['Trimetazidine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The chief director of department of cardiology', 'investigatorFullName': 'Ya-Wei Xu', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}