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Cardiovascular Risk Assessment Model in Patients With MI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03957005
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
National Institute for Medical Research Development
Information provided by (Responsible Party):
Masoumeh Sadeghi, Isfahan University of Medical Sciences

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.

Condition or disease
Myocardial Infarction, Acute

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cardiovascular Risk Assessment Model According to Behavioral, Psychosocial and Traditional Factors in Patients With Myocardial Infarction: A Multi-center Cohort Study
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Primary Outcome Measures :
  1. Incidence of MCE within follow up period [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03957005

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Contact: Hamidreza Roohafza, MD 00989137121274
Contact: Shervin Gh Hoseini, MD. PhD 009809131081854

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Iran, Islamic Republic of
Dr Heshmat Hospital Recruiting
Rasht, Gilan, Iran, Islamic Republic of
Contact: Aboozar Fakhrmousavi, MD    00989111364858   
Shahid Mohammadi hospital Recruiting
Bandar Abbas, Hormozgan, Iran, Islamic Republic of
Contact: Hossein Farshidi, MD    00989173613517   
Chamran Cardiology Hospital Recruiting
Isfahan, Iran, Islamic Republic of
Contact: Hamidreza Roohafza, MD    00989133152032   
Shahid Rajaei hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Feridoun Noohi, MD    00989121111248   
Sponsors and Collaborators
Isfahan University of Medical Sciences
National Institute for Medical Research Development
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Principal Investigator: Masoumeh Sadeghi, MD Cardiac Rehabilitation Research Center

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Responsible Party: Masoumeh Sadeghi, Head of Cardiac Rehabilitation Research Center, Isfahan University of Medical Sciences Identifier: NCT03957005     History of Changes
Other Study ID Numbers: 964708
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 months after study publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Masoumeh Sadeghi, Isfahan University of Medical Sciences:
Myocardial Infarction
Major cardiovascular events
Risk assessment
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases