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Clinical Trials/NCT02003781
NCT02003781UnknownNot Applicable

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

Yonsei University1 site in 1 country4,000 target enrollmentStarted: October 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
4,000
Locations
1
Primary Endpoint
Prognosis of high risk cardiovascular disease

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Prognosis of high risk cardiovascular disease

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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