| Condition or disease |
|---|
| Myocardial Infarction, Acute |
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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Hamidreza Roohafza, MD | 00989137121274 | hroohafza@gmail.com | |
| Contact: Shervin Gh Hoseini, MD. PhD | 009809131081854 | shghaffari@yahoo.com |
| 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 | |
| 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 |
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).
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| 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. |
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| Study Type | Observational | ||||||||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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. |
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| Recruitment Information | |||||||||||||||
| Recruitment Status | Recruiting | ||||||||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Masoumeh Sadeghi, Isfahan University of Medical Sciences | ||||||||||||||
| Study Sponsor | Isfahan University of Medical Sciences | ||||||||||||||
| Collaborators | National Institute for Medical Research Development | ||||||||||||||
| Investigators |
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| PRS Account | Isfahan University of Medical Sciences | ||||||||||||||
| Verification Date | May 2019 | ||||||||||||||