Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-02-21 @ 5:46 PM
Study NCT ID:
NCT02655718
Status:
UNKNOWN
Last Update Posted:
2016-01-14
First Post:
2015-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2015-12-29', 'studyFirstSubmitQcDate': '2016-01-13', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of inflammatory infiltrate, ischemia, infarction in the myocardial tissue', 'timeFrame': '14 days after ACS'}, {'measure': 'Left ventricular ejection fraction (Echo)', 'timeFrame': '14 days after ACS'}], 'secondaryOutcomes': [{'measure': 'Incidence of the acute myocardial infarction', 'timeFrame': '14 days after ACS'}, {'measure': 'Incidence of unstable angina', 'timeFrame': '14 days after ACS'}, {'measure': 'Incidence of Takotsubo syndrome', 'timeFrame': '14 days after ACS'}, {'measure': 'Incidence of myocarditis', 'timeFrame': '14 days after ACS'}, {'measure': 'Incidence of the mortality', 'timeFrame': '6 month and 12 month after ACS'}, {'measure': 'Incidence of the recurrent myocardial infarction', 'timeFrame': '6 month and 12 month after ACS'}, {'measure': 'Incidence of the heart failure', 'timeFrame': '6 month and 12 month after ACS'}, {'measure': 'Incidence of the stroke', 'timeFrame': '6 month and 12 month after ACS'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ACS', 'Non obstructive coronary atherosclerosis'], 'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess short and long term outcomes of acute coronary syndrome in patients with non obstructive coronary atherosclerosis, to optimize the algorithm for diagnosis and to evaluate its effectiveness', 'detailedDescription': 'The study non randomized, opened, controlled. Cardiovascular Magnetic - resonance imaging reveals both ischemic and non-ischemic causes of acute coronary syndrome. Currently, it is the best method for Imaging and damage assessment of myocardial viability in coronary atherosclerosis and noncoronary injuries (V.Yu.Usov 2012).\n\nTaking into account the results of previous (D. Kawecki, B. Morawiec, P. Monney, 2015) research, it can be concluded that the introduction of cardiovascular magnetic resonance imaging into routine practice will change the structure of morbidity among patients with acute coronary syndrome and non obstructive coronary atherosclerosis . The research was conducted on small groups of patients, and therefore further data acquisition is required.\n\nIt is planned to study 200 patients with acute coronary syndrome. On admission, they will receive the standard treatment of ACS with and without ST elevation. Within 72 hours they will performed diagnostic coronary angiography. If in case of non stenotic atherosclerosis of coronary artery (normal / stenosis \\< 50%) patients are planned for cardiac contrast MRI, which will identify both ischemic and non-ischemic causes of acute coronary syndrome. At 30 days, 6 months, 12 months the researchers will assess the clinical condition of the patients, perform cardiac ultrasound for the evaluation of myocardial contractile function, evaluate the incidence rate of secondary endpoints'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years at time of randomization (18 years and older)\n* acute coronary syndrome\n* no obstructive coronary atherosclerosis (normal coronary artety/ plaques \\<50%) is based on the results of coronary angiography for 3 days of admission\n* written the informed consent to participate in research\n\nExclusion Criteria:\n\n* patients previously undergone endovascular / surgical revascularization of coronary artery\n* severe comorbidity\n* Contacts/Locations'}, 'identificationModule': {'nctId': 'NCT02655718', 'acronym': 'NOCA', 'briefTitle': 'Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Russian Academy of Medical Sciences'}, 'officialTitle': 'Short and Long Term Outcomes of Acute Coronary Syndrome in Patients With Non Obstructive Coronary Atherosclerosis', 'orgStudyIdInfo': {'id': '2411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with ACS', 'description': 'Patients with ACS who underwent coronary angiography within 72 hours from the onset of disease. In identifying nonobstructive coronary atherosclerosis , patients underwent cardiac contrast MRI.', 'interventionNames': ['Other: Patients with ACS', 'Device: MRI']}], 'interventions': [{'name': 'Patients with ACS', 'type': 'OTHER', 'description': 'Cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images , T1-weighted images.', 'armGroupLabels': ['Patients with ACS']}, {'name': 'MRI', 'type': 'DEVICE', 'armGroupLabels': ['Patients with ACS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '634012', 'city': 'Tomsk', 'state': 'Tomskii Region', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Vyacheslav Ryabov, MD, Phd', 'role': 'CONTACT', 'email': 'rvvt@cardio-tomsk.ru', 'phone': '+73822553689'}, {'name': 'Vyacheslav Ryabov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Research Institutite for Cardiology', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'centralContacts': [{'name': 'Vyacheslav Ryabov, MD,PhD', 'role': 'CONTACT', 'email': 'rvvt@cardio-tomsk.ru', 'phone': '+73822553689'}, {'name': 'Sayana Gomboeva, MD', 'role': 'CONTACT', 'email': 'gomboevasayana@gmail.com', 'phone': '+73822558360'}], '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'}}}}