Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 11:04 PM
Study NCT ID:
NCT02562651
Status:
UNKNOWN
Last Update Posted:
2016-12-13
First Post:
2015-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Primary Anterior STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-20', 'releaseDate': '2017-05-30'}], 'estimatedResultsFirstSubmitDate': '2017-05-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D020257', 'term': 'Ventricular Remodeling'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart 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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-10', 'studyFirstSubmitDate': '2015-07-26', 'studyFirstSubmitQcDate': '2015-09-25', 'lastUpdatePostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in LV end-diastolic volumes index, %', 'timeFrame': '14 days and 6 month after STEMI'}], 'secondaryOutcomes': [{'measure': 'Incidence of cardiovascular death,%', 'timeFrame': '14 days and 6 month after STEMI'}, {'measure': 'Incidence of the recurrent myocardial infarction,%', 'timeFrame': '14 days and 6 month after STEMI'}, {'measure': 'Incidence of the angina,%', 'timeFrame': '14 days and 6 month after STEMI'}, {'measure': 'Incidence of the heart failure,%', 'timeFrame': '14 days and 6 month after STEMI'}, {'measure': 'Incidence of the stroke,%', 'timeFrame': '14 days and 6 month after STEMI'}, {'measure': 'Incidence of the combined endpoint,%', 'timeFrame': '14 days and 6 month after STEMI'}, {'measure': 'Incidence and severity of adverse events,%', 'timeFrame': '14 days and 6 month after STEMI'}, {'measure': 'Changes in 2 D global longitudinals strain,Δ %', 'timeFrame': '14 days and 6 month after STEMI'}, {'measure': 'Changes in MMPs and their inhibitors, other biomarkers, pg/ml', 'timeFrame': '14 days and 6 month after STEMI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['STEMI, adverse LVR (left ventricular remodeling), MMPs, Doxycycline'], 'conditions': ['Vascular Diseases', 'Cardiovascular Diseases', 'Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the changes of myocardial biomechanics and efficacy of doxycycline in patients with primary anterior STEMI.', 'detailedDescription': 'It is known that MMPs (matrix metalloproteinases) take part in myocardial remodeling, which lead to the adverse remodeling of left ventricular. Doxycycline inhibiting MMPs and it help to prevent collagen degradation and following LV (left ventricular) dilatation. Some experimental studies on rat models have suggested an anti-remodeling effect of doxycycline in myocardial infarction by means of decrease in activity of MMPs-2 and recovery of contractile function of myocardium. The clinical trial was performed at 2013 (D.Antoniucci), but it was a single study and confirmed theoretical and experimental background.\n\nThe study is randomized, opened, controlled. 45 patients with the first anterior STEMI will be enrolled. On admission all patients will receive reperfusion therapy during the first 24 h. Patients will be randomized by the open envelope method and after that some of the participants will be on doxycycline (100 mg b.i.d. for 7 days) in addition to routine medical therapy for STEMI, but other will be on routine medical therapy of STEMI. After that they will have echocardiography at 3-d, 7-th, 14-th days and 6 month after STEMI. The investigators will evaluate left ventricular function of these patients by routine and speckle-tracking echocardiography, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, also the investigators will take blood samples to assess metalloproteinases (MMPs) and other biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 and ≤ 75 years at time of randomization (18 years and older)\n* ST-elevation Q wave myocardial infarction\n* term admission to an intensive care unit (ICU) in the first 24 hours of onset\n* the reperfusion of the infarct-related coronary artery is not later than 24 hours after the initial onset of acute transmural myocardial infarction\n* written the informed consent to participate in research\n\nExclusion Criteria:\n\n* atrial fibrillation, a permanent form\n* valvular heart disease\n* severe comorbidity\n* acute heart failure according to the Killip classification IV FC (functional class)\n* history of chronic heart failure (NYHA III-IV)\n* poor image quality for Echocardiography\n* sinus bradycardia - heart rate of under 50 beats per minute, interventricular conduction delay (QRS \\> 0,11 s.) and atrioventricular block II-III degree'}, 'identificationModule': {'nctId': 'NCT02562651', 'acronym': 'MASTARD', 'briefTitle': 'Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Primary Anterior STEMI', 'organization': {'class': 'OTHER', 'fullName': 'Russian Academy of Medical Sciences'}, 'officialTitle': 'Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Acute Primary Anterior STEMI (ST Segment Elevation Myocardial Infarction)', 'orgStudyIdInfo': {'id': '1202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Doxycycline', 'description': '100 mg of Doxycycline bid for seven days in pts with STEMI underwent PCI (percutaneous coronary intervention) and with current medical therapy', 'interventionNames': ['Drug: Doxycycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active comparator', 'description': 'Standard care for STEMI', 'interventionNames': ['Other: Standard care for STEMI']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'otherNames': ['Doxycycline Solutab'], 'description': 'Doxycycline bid for the first 7 days after primary anterior STEMI', 'armGroupLabels': ['Doxycycline']}, {'name': 'Standard care for STEMI', 'type': 'OTHER', 'otherNames': ['Invasive and medical treatment for STEMI'], 'description': 'Invasive and medical treatment for STEMI according to guidelines', 'armGroupLabels': ['Active comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '634012', 'city': 'Tomsk', 'state': 'Tomskii Region', 'country': 'Russia', 'facility': 'Research Institutite for Cardiology', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'overallOfficials': [{'name': 'Vyacheslav Ryabov, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Institute for Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Russian Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD Research Institute for Cardiology', 'investigatorFullName': 'Vyacheslav Ryabov', 'investigatorAffiliation': 'Russian Academy of Medical Sciences'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-05-30', 'type': 'RELEASE'}, {'date': '2017-10-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Vyacheslav Ryabov, MD, PhD Research Institute for Cardiology, Russian Academy of Medical Sciences'}}}}