Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT01615003
Status:
UNKNOWN
Last Update Posted:
2014-01-14
First Post:
2012-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Study of MicroRNA Genomics of Blood Stasis Syndrome and of Coronary Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-12', 'studyFirstSubmitDate': '2012-05-28', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina', 'timeFrame': '1 month', 'description': 'The change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina by real RT-PCR.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MicroRNA', 'coronary heart disease', 'unstable angina', 'blood stasis syndrome', 'Xuesaitong soft capsule'], 'conditions': ['Coronary Heart Disease', 'Unstable Angina', 'Blood Stasis Syndrome']}, 'descriptionModule': {'briefSummary': 'In this study, typical cases of blood stasis syndrome of coronary heart disease are selected, by using microRNA chip, cDNA microarray and other bioinformatics technologies to filter and verify related miRNA and its target gene of Coronary Heart disease. Meanwhile, intervene by Xuesaitong soft capsules to investigate related miRNA and its target gene of Coronary Heart disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of coronary angiography unstable angina\n* Clinical diagnosis of unstable angina\n* Age of 30 to 75 years old\n* Not use thrombolysis, dilate coronary drugs within two weeks\n* Tongue dark\n* Sign the consent\n\nExclusion Criteria:\n\n* Severe valvular heart disease\n* Insulin-dependent diabetes\n* mental disease\n* Combined with severe liver, kidney, hematopoietic system disorder\n* Patients with malignant tumors\n* Pregnancy or breast-feeding women\n* Recent history of trauma\n* Drug allergy'}, 'identificationModule': {'nctId': 'NCT01615003', 'briefTitle': 'The Study of MicroRNA Genomics of Blood Stasis Syndrome and of Coronary Heart Disease', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'The Analysis of Blood Stasis Syndromeand of Coronary Heart Disease Related MicroRNA Genomics and Target Gene Regulatory Networks', 'orgStudyIdInfo': {'id': 'NNSF81173116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xuesaitong soft capsule group', 'description': 'Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and Xuesaitong soft capsule.', 'interventionNames': ['Drug: Xuesaitong soft capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and placebo.', 'interventionNames': ['Drug: Xuesaitong soft capsule Placebo']}], 'interventions': [{'name': 'Xuesaitong soft capsule', 'type': 'DRUG', 'description': 'Xuesaitong soft capsule, soft capsule, Ingredients:PNS, Specification:0.33 per bag, once take two pills and twice a day during a month.', 'armGroupLabels': ['Xuesaitong soft capsule group']}, {'name': 'Xuesaitong soft capsule Placebo', 'type': 'DRUG', 'description': 'Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Teng, master', 'role': 'CONTACT', 'email': 'echo-teng@126.com', 'phone': '13581985462'}, {'name': 'Gui Yu, master', 'role': 'CONTACT', 'phone': '13488835663'}, {'name': 'Jie Wang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guang'an men Hispital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fei Teng, master', 'role': 'CONTACT', 'email': 'echo-teng@126.com', 'phone': '13581985462'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}