Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02158559
Status:
UNKNOWN
Last Update Posted:
2014-06-09
First Post:
2014-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540581', 'term': 'danhong'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-05', 'studyFirstSubmitDate': '2014-05-29', 'studyFirstSubmitQcDate': '2014-06-05', 'lastUpdatePostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.', 'detailedDescription': 'Research Topic.\n\n* A randomized, double-blind, placebo-controlled, multi-center clinical trial of the effect of Danhong Injection on microcirculation in the treatment of patients with STEMI(ST- elevation myocardical infarction) after the PTCA surgery.\n\nResearch Purpose.\n\n* This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.\n\nResearch design.\n\n* A randomized, double-blind, placebo-controlled, multi-center clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically definite or laboratory-supported diagnosis of STEMI ,with the indication of PTCA surgery.\n* 18≤Age≤75;\n* Agreed to join in the study and signed the inform consent form.\n\nExclusion Criteria:\n\n* Cardiogenic shock , Killip III-IV degree , papillary muscle rupture , septal perforation , episodes of ventricular tachycardia and ventricular fibrillation after electrical cardioversion , temporary pacemaker implanted AVB III degree.\n* Past history of PCI and CABG\n* Acute or chronic infectious diseases(for example severe pneumonia);\n* Recent history of hemorrhagic stroke(within six months)\n* Combined with liver and kidney dysfunction;\n* History of valvular heart disease;\n* Congenital heart disease or Pulmonary hypertension;\n* All kinds of history of cardiomyopathy;\n* Bleeding and other thrombotic diseases;\n* Severe anemia , thrombocytopenia , Other diseases of the blood system;\n* Cancer , Autoimmune disease , All kinds of the patients who use the glucocorticoid and immunosuppressor;\n* Menstrual period women, pregnant women and lactating women, pregnancy test positive or recent family planning.'}, 'identificationModule': {'nctId': 'NCT02158559', 'acronym': 'Danhong', 'briefTitle': 'the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Bozhiyin T&S Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI(ST- Elevation Myocardical Infarction) After the PTCA Surgery.', 'orgStudyIdInfo': {'id': 'DH-140318-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Danhong Injection', 'description': 'Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;', 'interventionNames': ['Drug: Danhong Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': '0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Danhong Injection', 'type': 'DRUG', 'description': 'Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;', 'armGroupLabels': ['Danhong Injection']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': '0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;', 'armGroupLabels': ['Normal Saline']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Bozhiyin T&S Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}