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出境医 / 临床实验 / Cardiovascular Risk Assessment Model in Patients With MI

Cardiovascular Risk Assessment Model in Patients With MI

Study Description
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.

Study Design
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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
Arms and Interventions
Outcome Measures
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).


Eligibility Criteria
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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.
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.
Contacts and Locations

Contacts
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Contact: Hamidreza Roohafza, MD 00989137121274 hroohafza@gmail.com
Contact: Shervin Gh Hoseini, MD. PhD 009809131081854 shghaffari@yahoo.com

Locations
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Iran, Islamic Republic of
Dr Heshmat Hospital Recruiting
Rasht, Gilan, Iran, Islamic Republic of
Contact: Aboozar Fakhrmousavi, MD    00989111364858    aboozar.fakhrmousavi@gmail.com   
Shahid Mohammadi hospital Recruiting
Bandar Abbas, Hormozgan, Iran, Islamic Republic of
Contact: Hossein Farshidi, MD    00989173613517    hfarshidi6@gmail.com   
Chamran Cardiology Hospital Recruiting
Isfahan, Iran, Islamic Republic of
Contact: Hamidreza Roohafza, MD    00989133152032    hroohafza@gmail.com   
Shahid Rajaei hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Feridoun Noohi, MD    00989121111248    fnoohib@yahoo.com   
Sponsors and Collaborators
Isfahan University of Medical Sciences
National Institute for Medical Research Development
Investigators
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Principal Investigator: Masoumeh Sadeghi, MD Cardiac Rehabilitation Research Center
Tracking Information
First Submitted Date May 17, 2019
First Posted Date May 21, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date November 6, 2018
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2019)
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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Myocardial Infarction, Acute
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 17, 2019)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hamidreza Roohafza, MD 00989137121274 hroohafza@gmail.com
Contact: Shervin Gh Hoseini, MD. PhD 009809131081854 shghaffari@yahoo.com
Listed Location Countries Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03957005
Other Study ID Numbers 964708
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 6 months after study publication.
Responsible Party Masoumeh Sadeghi, Isfahan University of Medical Sciences
Study Sponsor Isfahan University of Medical Sciences
Collaborators National Institute for Medical Research Development
Investigators
Principal Investigator: Masoumeh Sadeghi, MD Cardiac Rehabilitation Research Center
PRS Account Isfahan University of Medical Sciences
Verification Date May 2019