NCT03957005

Cardiovascular Risk Assessment Model in Patients With MI

A Cardiovascular Risk Assessment Model According to Behavioral, Psychosocial and Traditional Factors in Patients With Myocardial Infarction: A Multi-center Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Isfahan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction, Acute

Timeline

• Start date: 2018-11-06
• Primary completion: 2023-05-01
• Completion: 2023-11-01
• First posted: 2019-05-21
• Last updated: 2019-05-21

Locations

4 sites across 1 country: Iran