Cardiovascular Risk Assessment Model in Patients With MI

Myocardial Infarction, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03957005
• Other study ID #: 964708
• Status: Recruiting
• Start date: November 6, 2018
• Est. completion date: November 2023

Study information

• Verified date: May 2019
• Source: Isfahan University of Medical Sciences
• Contact: Hamidreza Roohafza, MD
• Phone: 00989137121274
• Email: hroohafza[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: November 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• clinically verified diagnosis of the first episode ST-elevation myocardial infarction

• providing written informed consent

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Mohammadi hospital	Bandar Abbas	Hormozgan
Iran, Islamic Republic of	Chamran Cardiology Hospital	Isfahan
Iran, Islamic Republic of	Dr Heshmat Hospital	Rasht	Gilan
Iran, Islamic Republic of	Shahid Rajaei hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences	National Institute for Medical Research Development

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of MCE within follow up period	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).	From enrollment up to 36 months of followup