Clinical trial NCT03957005: Cardiovascular Risk Assessment Model in Patients With MI
Official title: A Cardiovascular Risk Assessment Model According to Behavioral, Psychosocial and Traditional Factors in Patients With Myocardial Infarction: A Multi-center Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction, Acute
Keywords: Myocardial Infarction
Major cardiovascular events
Risk assessment
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research Development
First posted: 2019-05-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of MCE within follow up period
timeFrame: From enrollment up to 36 months of followup
Secondary outcomes:
Other outcomes:
Locations:
city: Rasht
country: Iran, Islamic Republic of
facility: Dr Heshmat Hospital
state: Gilan
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Shahid Mohammadi hospital
state: Hormozgan
city: Isfahan
country: Iran, Islamic Republic of
facility: Chamran Cardiology Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Rajaei hospital
Study officials:
affiliation: Cardiac Rehabilitation Research Center
name: Masoumeh Sadeghi, MD
role: PRINCIPAL_INVESTIGATOR
References: