Clinical trial NCT02003781: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High Risk Cardiovascular Disease Patients
Keywords: cardiovascular disease
metabolic disease
high risk
prospective cohort
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 4000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: high risk cardiovascular disease patients and their relatives

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prognosis of high risk cardiovascular disease
timeFrame: 10 year after recruting
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Seo J, Lee CJ, Oh J, Lee SH, Kang SM, Park S. Large discrepancy between unobserved automated office blood pressure and ambulatory blood pressure in a high cardiovascular risk cohort. J Hypertens. 2019 Jan;37(1):42-49. doi: 10.1097/HJH.0000000000001868.
citation: Park S, Lee CJ, Jhee JH, Yun HR, Kim H, Jung SY, Kee YK, Yoon CY, Park JT, Kim HC, Han SH, Kang SW, Park S, Yoo TH. Extracellular Fluid Excess Is Significantly Associated With Coronary Artery Calcification in Patients With Chronic Kidney Disease. J Am Heart Assoc. 2018 Jun 30;7(13):e008935. doi: 10.1161/JAHA.118.008935.
citation: Joo WT, Lee CJ, Oh J, Kim IC, Lee SH, Kang SM, Kim HC, Park S, Youm Y. The Association between Social Network Betweenness and Coronary Calcium: A Baseline Study of Patients with a High Risk of Cardiovascular Disease. J Atheroscler Thromb. 2018 Feb 1;25(2):131-141. doi: 10.5551/jat.40469. Epub 2017 Jul 21.
citation: Oh J, Lee CJ, Kim IC, Lee SH, Kang SM, Choi D, Park S, Kario K. Association of Morning Hypertension Subtype With Vascular Target Organ Damage and Central Hemodynamics. J Am Heart Assoc. 2017 Feb 14;6(2):e005424. doi: 10.1161/JAHA.116.005424.