Cardiovascular Risk Assessment Model in Patients With MI
- Conditions
- Myocardial Infarction, Acute
- Registration Number
- NCT03957005
- Lead Sponsor
- Isfahan University of Medical Sciences
- Brief Summary
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.
- Detailed Description
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.
The 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
- clinically verified diagnosis of the first episode ST-elevation myocardial infarction
- providing written informed consent
- history of prior documented CVD
- living in a nursing home or other institutions
- having a serious medical condition with a survival of less than 3 years
- participation in another scientific study
- not willing to participate in each phase of the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of MCE within follow up period From enrollment up to 36 months of followup 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Shahid Rajaei hospital
🇮🇷Tehran, Iran, Islamic Republic of
Chamran Cardiology Hospital
🇮🇷Isfahan, Iran, Islamic Republic of
Dr Heshmat Hospital
🇮🇷Rasht, Gilan, Iran, Islamic Republic of
Shahid Mohammadi hospital
🇮🇷Bandar Abbas, Hormozgan, Iran, Islamic Republic of