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临床试验/NCT03957005
NCT03957005Unknown不适用

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

Isfahan University of Medical Sciences4 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年11月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
4
主要终点
Incidence of MCE within follow up period

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinically verified diagnosis of the first episode ST-elevation myocardial infarction
  • providing written informed consent

排除标准

  • 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.

结局指标

主要结局

Incidence of MCE within follow up period

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Masoumeh Sadeghi

Head of Cardiac Rehabilitation Research Center

Isfahan University of Medical Sciences

研究点 (4)

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