Cardiovascular Risk Assessment Model in Patients With MI

NCT ID: NCT03957005

Last Updated: 2019-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-06

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction, Acute

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute for Medical Research Development

UNKNOWN

Sponsor Role collaborator

Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Masoumeh Sadeghi

Head of Cardiac Rehabilitation Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Masoumeh Sadeghi, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiac Rehabilitation Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr Heshmat Hospital

Rasht, Gilan Province, Iran

Site Status RECRUITING

Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, Iran

Site Status RECRUITING

Chamran Cardiology Hospital

Isfahan, , Iran

Site Status RECRUITING

Shahid Rajaei hospital

Tehran, , Iran

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Iran

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hamidreza Roohafza, MD

Role: CONTACT

00989137121274

Shervin Gh Hoseini, MD. PhD

Role: CONTACT

009809131081854

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aboozar Fakhrmousavi, MD

Role: primary

00989111364858

Hossein Farshidi, MD

Role: primary

00989173613517

Hamidreza Roohafza, MD

Role: primary

00989133152032

Feridoun Noohi, MD

Role: primary

00989121111248

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

964708

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The MI-HEART Project
NCT00013741 COMPLETED NA