Individualized Prevention Strategy for High Risk Patients in Cardiovascular Disease: Prospective Cohort Study (Cardiovascular and Metabolic Disease Etiology Research Center - HIgh Risk Cohort) CMERC-HI

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02003781

Collaborator

(none)

4,000

Enrollment

Location

120

Duration (Months)

33.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Set the prospective cohort (CMERC-HI) to study the known and novel etiologies and related factors for predicting clinical outcomes in Korean patients with high risk cardiovascular disease.

Condition or Disease	Intervention/Treatment	Phase
High Risk Cardiovascular Disease Patients

Study Design

Study Type:

Observational

Anticipated Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
cardiovascular disease high risk cardiovascular disease patients and their relatives

Outcome Measures

Primary Outcome Measures

Prognosis of high risk cardiovascular disease [10 year after recruting]
all-cause mortality, cardiovascular mortality, non-cardiovascular mortality new onset of acute myocardial infarction, acute coronary syndrome, heart failure, stroke, peripheral artery disease, hospitalization for revascularization and these disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

high risk hypertension patients a. eGFR > 60 with one of target organ damages b. eGFR <= 60
diabetes mellitus with microalbumin ration (AC ratio >= 30mg/g)
anuric ESRD patients on dialysis
the relatives of acute myocardial infarction patients under 55 years old (men)/ 65 years old (women)
atherosclerotic cardiovascular disease (abdominal aorta diameter ≥3 cm or ankle-brachial index <0.9, or carotid plaque or carotid intima-media thickness ≥0.9 mm, or asymptomatic old cerebrovascular accident, or >30% stenosis in at least one major coronary artery)
rheumatoid arthritis patients aged > 40 years on MTX and steroid therapy
atrial fibrillation patients with CHADS-VASc Score ≥ 1
kidney transplant recipient at > 3 months after transplantation

Exclusion Criteria:

acute myocardial infarction, acute coronary syndrome patients, symptomatic coronary artery disease or history of these diseases
symptomatic peripheral artery disease, heart failure and history of these diseases
desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis)
women with pregnancy or on nursing
history of contrast allergy and related side effects
within the first three months after transplantation
acute renal allograft rejection