Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT03677466
Status:
COMPLETED
Last Update Posted:
2019-04-05
First Post:
2018-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramyocardial Haemorrhage in Patients With Primary STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077785', 'term': 'Tenecteplase'}, {'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'D013300', 'term': 'Streptokinase'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2018-09-17', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intramyocardial haemorrhage in primary STEMI measure', 'timeFrame': '2 days', 'description': 'Intramyocardial haemorrhage (%) in patients with primary STEMI as assessed by cardiac magnetic resonance imaging 2 days after reperfusion'}], 'secondaryOutcomes': [{'measure': 'Left ventricular ejection fraction (LVEF) recovery measure', 'timeFrame': '3 months (with intermediate measurement at day 7 after reperfusion)', 'description': 'Left ventricular ejection fraction (LVEF) (%) recovery measured with echocardiography 7 days and 3 months after reperfusion strategies'}, {'measure': 'Global Longitudinal Strain', 'timeFrame': '3 months (with intermediate measurement at day 7 after reperfusion)', 'description': 'Global Longitudinal Strain (%) measured with echocardiography 7 days and 3 months after reperfusion strategies'}, {'measure': 'Recurrent myocardial infarction measure', 'timeFrame': '3 months', 'description': 'Incidence of recurrent myocardial infarction (%) 3 months after STEMI'}, {'measure': 'Heart failure incidence measure', 'timeFrame': '3 months', 'description': 'Incidence of heart failure (%) 3 months after STEMI'}, {'measure': 'Stroke incidence measure', 'timeFrame': '3 months', 'description': 'Incidence of stroke (%) 3 months after STEMI'}, {'measure': 'Mortality measure', 'timeFrame': '3 months', 'description': 'Mortality rate (%) 3 months after STEMI'}, {'measure': 'Major bleeding incidence measure', 'timeFrame': '3 months', 'description': 'Incidence of major bleeding (%) 3 months after STEMI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intramyocardial haemorrhage', 'Myocardial Infarction', 'ST Elevation Myocardial Infarction', 'Primary Percutaneous Coronary Intervention', 'Pharmaco invasive strategy', 'Fibrinolytic therapy', 'Global longitudinal strain', 'Myocardial Necrosis', 'Coronary Artery Disease'], 'conditions': ['Myocardial Infarction', 'STEMI', 'Myocardial Necrosis', 'Myocardial Injury']}, 'referencesModule': {'references': [{'pmid': '25212800', 'type': 'RESULT', 'citation': 'Hamirani YS, Wong A, Kramer CM, Salerno M. Effect of microvascular obstruction and intramyocardial hemorrhage by CMR on LV remodeling and outcomes after myocardial infarction: a systematic review and meta-analysis. JACC Cardiovasc Imaging. 2014 Sep;7(9):940-52. doi: 10.1016/j.jcmg.2014.06.012.'}, {'pmid': '26763281', 'type': 'RESULT', 'citation': 'Carrick D, Haig C, Ahmed N, McEntegart M, Petrie MC, Eteiba H, Hood S, Watkins S, Lindsay MM, Davie A, Mahrous A, Mordi I, Rauhalammi S, Sattar N, Welsh P, Radjenovic A, Ford I, Oldroyd KG, Berry C. Myocardial Hemorrhage After Acute Reperfused ST-Segment-Elevation Myocardial Infarction: Relation to Microvascular Obstruction and Prognostic Significance. Circ Cardiovasc Imaging. 2016 Jan;9(1):e004148. doi: 10.1161/CIRCIMAGING.115.004148.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the frequency and intensity of intramyocardial haemorrhage in patients with primary STEMI and different reperfusion strategies.', 'detailedDescription': 'The study non-randomized, opened, controlled. In half of patients despite on carried in-time reperfusion therapy intramyocardial haemorrhage determined after a long-term period of severe ischemia. Earlier, definition of intramyocardial haemorrhage was possible only by autopsy. Nowaday, cardiac contrast MRI is the best diagnostic method, which allows to assess the regional and global function of the LV, structural changes in myocardial tissue and also in T2 mode it became assessable to reveal intramyocardial haemorrhage.\n\nTaking into account the results of previous researches, it can be concluded that the intramyocardial haemorrhage was determined in half of patients with primary PCI \\[1\\]. An influence of fibrinolytic therapy to the intramyocardial haemorrhage was conducted in small group of patients in one trial, and therefore further data will be actual and useful \\[2\\].\n\nIt is planned to study 60 patients with primary STEMI using standard therapy. The patients will be divided into 2 groups. Patients of the 1st group will be treated by pharmaco-invasive strategy. The 2nd group will be treated by primary PCI. Patients in all groups after reperfusion strategies will be conducted cardiac contrast MRI for detection intramyocardial haemorrhage within 2 days onset. At day 7 and through 3 months, the clinical condition of the patients will be assessed and cardiac ultrasound will be performed for the evaluation of myocardial contractile function and 2D global longitudinal strain. Also, the incidence rate of secondary endpoints will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years at time of randomization (18 years and older);\n* Acute myocardial infarction;\n* Reperfusion of the infarct-related coronary artery in terms within 12 h of symptom onset;\n* Written the informed consent to participate in research;\n\nExclusion Criteria:\n\n* Inability to obtain informed consent;\n* Patients previously undergone endovascular / surgical revascularization of coronary artery;\n* Severe comorbidity;\n* History of myocardial infarction;\n* History of intracranial haemorrhage;\n* Pulmonary edema, cardiogenic shock;\n* Creatinine clearance \\<30 mL/min or dialysis;\n* Unable to undergo or contra-indications for MRI;\n* Allergy for contrast agent;\n* Indication or use of oral anticoagulant therapy;\n* Major bleedind;\n* Atrio-ventricular block II and III degree;\n* Active gastroduodenal ulcer;\n* Aortic dissection;\n* Acute psychotic disorders'}, 'identificationModule': {'nctId': 'NCT03677466', 'acronym': 'HaemInCor', 'briefTitle': 'Intramyocardial Haemorrhage in Patients With Primary STEMI', 'organization': {'class': 'OTHER', 'fullName': 'Tomsk National Research Medical Center of the Russian Academy of Sciences'}, 'officialTitle': 'Clinical Trial Appreciating Intramyocardial Haemorrhage in Patients With Primary STEMI and Different Reperfusion Strategies (Pharmaco Invasive Strategy and Primary PCI)', 'orgStudyIdInfo': {'id': 'HaemInCor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmaco-invasive strategy', 'description': 'Fibrinolytic therapy (Streptokinase, Alteplasa, Tenecteplasa in standard dose) is conducted within 12 h of symptom onset in the pre-hospital setting if primary PCI cannot be performed within 120 min from STEMI diagnosis. Then PCI is performed to all of patients.', 'interventionNames': ['Drug: Pharmaco-invasive strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Primary PCI', 'description': 'Primary percutaneous coronary intervention (PCI) in patients with primary STEMI', 'interventionNames': ['Procedure: Primary PCI']}], 'interventions': [{'name': 'Pharmaco-invasive strategy', 'type': 'DRUG', 'otherNames': ['Metalyse', 'Actilyse', 'Tenecteplase', 'Alteplase', 'Streptokinase'], 'description': 'Patient with primary STEMI will received standard doses of fibrinolytics with following PCI.\n\nAfter reperfusion strategies will be conducted cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images, T1-weighted images. and Global Longitudinal Strain measured with echocardiography.', 'armGroupLabels': ['Pharmaco-invasive strategy']}, {'name': 'Primary PCI', 'type': 'PROCEDURE', 'description': 'After primary PCI patients will be conducted cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images, T1-weighted images and Global Longitudinal Strain measured with echocardiography.', 'armGroupLabels': ['Primary PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '634012', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'Cardiology Research Institute', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'overallOfficials': [{'name': 'Evgeny V. Vyshlov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tomsk NRMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tomsk National Research Medical Center of the Russian Academy of Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}