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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

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ClinicalTrials.gov Identifier: NCT02003781
Recruitment Status : Recruiting
First Posted : December 6, 2013
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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
High Risk Cardiovascular Disease Patients

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2013
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Group/Cohort
cardiovascular disease
high risk cardiovascular disease patients and their relatives



Primary Outcome Measures :
  1. 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



Biospecimen Retention:   Samples With DNA
serum, whole blood, urine, DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
high risk cardiovascular disease patients and their relatives
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003781


Contacts
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Contact: Sungha Park, MD 82-2-2228-8455 shpark0530@yuhs.ac

Locations
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Korea, Republic of
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sungha Park, MD    82-2-2228-8455    shpark0530@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02003781    
Other Study ID Numbers: 4-2013-0581
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Keywords provided by Yonsei University:
cardiovascular disease
metabolic disease
high risk
prospective cohort
Additional relevant MeSH terms:
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Cardiovascular Diseases
Metabolic Diseases