High Risk Cardiovascular Disease Patients Clinical Trial
| NCT number | NCT02003781 |
| Other study ID # | 4-2013-0581 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2013 |
| Est. completion date | October 2023 |
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.
| Status | Recruiting |
| Enrollment | 4000 |
| Est. completion date | October 2023 |
| Est. primary completion date | October 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prognosis of high risk cardiovascular disease | 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 |
10 year after recruting |