High Risk Cardiovascular Disease PatientsNCT02003781
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
An observational study of High Risk Cardiovascular Disease Patients, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- High Risk Cardiovascular Disease Patients
- How many people
- 4,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: high risk cardiovascular disease patients and their relatives
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752
Sungha Park, MD, 82-2-2228-8455, shpark0530@yuhs.ac
About this study
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.
- Keywords
- cardiovascular disease, metabolic disease, high risk, prospective cohort
- Medical subject headings
- Cardiovascular Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cardiovascular disease | high risk cardiovascular disease patients and their relatives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 year after recruting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High Risk Cardiovascular Disease PatientsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003781
- Sponsor's protocol ID
- 4-2013-0581
- Status last verified
- Jul 2018
- First submitted
- 2 Dec 2013
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30507862Park 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.
PubMed 29960990Joo 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.
PubMed 28740058Oh 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.
PubMed 28196818
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02003781
- Acronym / sponsor ID
- 4-2013-0581
- Keywords
- cardiovascular disease, metabolic disease, high risk, prospective cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiovascular disease | – | –high risk cardiovascular disease patients and their relatives |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- high risk cardiovascular disease patients and their relatives
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Derived from this study: PubMed 30507862Seo 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.
- Derived from this study: PubMed 29960990Park 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.
- Derived from this study: PubMed 28740058Joo 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.
- Derived from this study: PubMed 28196818Oh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk Cardiovascular Disease Patients, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sungha Park, MD (82-2-2228-8455, shpark0530@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis of high risk cardiovascular disease (time frame: 10 year after recruting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003781, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.