Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT03957005
Status:
UNKNOWN
Last Update Posted:
2019-05-21
First Post:
2019-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk Assessment Model in Patients With MI
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2019-05-17', 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of MCE within follow up period', 'timeFrame': 'From enrollment up to 36 months of followup', 'description': 'MCE includes two type of CV events: coronary artery disease-specific (MI, unstable angina (hospitalized angina), coronary revascularization or death from coronary heart disease) and cerebrovascular disease-specific events (ischemic or hemorrhagic stroke, transient ischemic attack, cerebrovascular disease-specific revascularization or death from cerebrovascular disease).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial Infarction', 'Major cardiovascular events', 'Risk assessment'], 'conditions': ['Myocardial Infarction, Acute']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate life-style and psycho social factors of major cardiovascular events in patients with myocardial infarction in three different provinces of Iran and to design a risk assessment chart for major cardiovascular events in patients with MI.', 'detailedDescription': 'Patients with pre-existing MI are at higher risk of major cardiovascular events (MCE). Current studies mainly focus on cardiovascular disease (CVD) risk assessment in general population without a history of CVD. Because of high prevalence of ischemic heart disease, especially in developing countries such as Iran, this group of patients form a large high-risk population. Factors such as life styles, habits, and psychosocial features are adjustable factors which have been less studied in relation to MCE in MI patients worldwide. Psychological factors are especially most important in patients with a pre-existing CVD and can account for worse outcomes independent of other pathological factors. The cardiovascular events are multifactorial and control of traditional risk factors such as hypertension and hyperlipidemia cannot efficiently reduce MCE. Identification and comprehensive assessment of MCE risk factors is essential for reducing MCE and thus better management of patients. The effect of different factors on MCE could be analysed using risk assessment model. To the best of our knowledge, this is the first comprehensive study of life style and psychological risk factors in CVD patients and the first time to perform MCE risk assessment modelling in MI patients.\n\nThe predictors recorded in this study are categorized in three main issues: 1) lifestyle, including: nutritional status, physical activity, tobacco smoking and drug abuse, sleep quality, and sexual function assessed by relevant questionnaires. 2) behavioral and psychological factors, including: depression, psychological distress, health anxiety, health related quality of life, type D personality, coping strategies, sense of coherence and medication adherence also measured by appropriate questionnaires. 3) Traditional risk factors, including: hypertension, diabetes, and hyperlipidemia which will be extracted from medical and laboratory records of patients and questionnaires. All predictor variables will be assessed in every year follow-up for three years during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will perform in three referral hospitals of Tehran, Isfahan and Bandarabbas counties. Participants of this study will be those hospitalized because of their first myocardial infarction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically verified diagnosis of the first episode ST-elevation myocardial infarction\n* providing written informed consent\n\nExclusion Criteria:\n\n* history of prior documented CVD\n* living in a nursing home or other institutions\n* having a serious medical condition with a survival of less than 3 years\n* participation in another scientific study\n* not willing to participate in each phase of the study.'}, 'identificationModule': {'nctId': 'NCT03957005', 'briefTitle': 'Cardiovascular Risk Assessment Model in Patients With MI', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'A Cardiovascular Risk Assessment Model According to Behavioral, Psychosocial and Traditional Factors in Patients With Myocardial Infarction: A Multi-center Cohort Study', 'orgStudyIdInfo': {'id': '964708'}}, 'contactsLocationsModule': {'locations': [{'city': 'Rasht', 'state': 'Gilan Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Aboozar Fakhrmousavi, MD', 'role': 'CONTACT', 'email': 'aboozar.fakhrmousavi@gmail.com', 'phone': '00989111364858'}], 'facility': 'Dr Heshmat Hospital', 'geoPoint': {'lat': 37.27611, 'lon': 49.58862}}, {'city': 'Bandar Abbas', 'state': 'Hormozgan', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Hossein Farshidi, MD', 'role': 'CONTACT', 'email': 'hfarshidi6@gmail.com', 'phone': '00989173613517'}], 'facility': 'Shahid Mohammadi hospital', 'geoPoint': {'lat': 27.1865, 'lon': 56.2808}}, {'city': 'Isfahan', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Hamidreza Roohafza, MD', 'role': 'CONTACT', 'email': 'hroohafza@gmail.com', 'phone': '00989133152032'}], 'facility': 'Chamran Cardiology Hospital', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}, {'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Feridoun Noohi, MD', 'role': 'CONTACT', 'email': 'fnoohib@yahoo.com', 'phone': '00989121111248'}], 'facility': 'Shahid Rajaei hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Hamidreza Roohafza, MD', 'role': 'CONTACT', 'email': 'hroohafza@gmail.com', 'phone': '00989137121274'}, {'name': 'Shervin Gh Hoseini, MD. PhD', 'role': 'CONTACT', 'email': 'shghaffari@yahoo.com', 'phone': '009809131081854'}], 'overallOfficials': [{'name': 'Masoumeh Sadeghi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiac Rehabilitation Research Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6 months after study publication.', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Medical Research Development', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiac Rehabilitation Research Center', 'investigatorFullName': 'Masoumeh Sadeghi', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}