Coronary Artery Disease (CAD)NCT02083146
C1q/TNF-related Proteins in Coronary Artery Disease
An observational study of Coronary Artery Disease (CAD), run by Korea University at 1 site in South Korea.
Trial summary
Now, adipose tissue is established as an active endocrine organ that controls systemic energy homeostasis by secretion of adipokines. Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been reported to share structural homology with adiponectin. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease (CAD)
- How many people
- 362 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Feb 2016
- 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: The subjects with stable angina or a history of acute coronary syndrome who visited for a department of cardiology in Korea Univ. Guro hospital were enrolled using predefined inclusion and exclusion criteria.
Who may be able to join
- 20<age<80
- History of stable angina, unstable angina, or acute myocardial infarction
Who cannot join
- a history of diabetes
- stage 2 hypertension
- malignancy
- severe renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Now, adipose tissue is established as an active endocrine organ that controls systemic energy homeostasis by secretion of adipokines. Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been reported to share structural homology with adiponectin. To date, 15 CTRP family members have been found that might play major roles in metabolism and inflammation. The investigators tried to clarify the relationship between CTRP family and coronary artery disease (CAD) in Korean men and women.
Read the detailed description
Adipose tissue secretes various kinds of bioactive molecules termed adipokines which contribute to the development of obesity-related disorders including cardiovascular disease (CVD). Adiponectin is the insulin-sensitizing adipokine with anti-inflammatory and anti-atherogenic properties. Hypoadiponectinemia has been associated with an increased risk of coronary artery disease (CAD) in several though not all studies. Recently, a new family of secreted proteins, C1q/TNF-related protein (CTRP), was cloned on the basis of sequence homology with adiponectin. This family of adiponectin paralogs might have pivotal implications in energy homeostasis and obesity-related inflammation. Each CTRP family member has its own unique tissue expression profile and function in regulating glucose and/or fat metabolism. In the present study, we evaluated the role of CTRP in patients with CAD and investigated whether CTRP family is significantly associated with CAD prevalence after adjustment for well-known CAD risk factors.
- Conditions
- Coronary Artery Disease (CAD)
- Medical subject headings
- Coronary Artery Disease
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 |
|---|---|---|
| Patients with CAD | Acute coronary syndromoe (ACS) patients who were admitted to the coronary care unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum concentration of CTRP-1,3, or 9 in the subjects with/without CAD
compare serum concentration of CTRP-1,3 or 9 between CAD patients and normal group
Measured: at enrollment
Secondary outcomes (1)
The relationships of serum CTRPs/adiponectin levels with cardiometabolic risk profiles
find the correlation of CTRPs and adiponection with cardiometabolic risk
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionFeb 2016
Why it stopped: Study subjects were not enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung Mook Choi, Korea University
- Investigators
- Kyung Mook Choi, M.D., Principal investigator, medica7@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083146
- Sponsor's protocol ID
- CAD(CTRP)
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2014
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C1q/TNF-related Proteins in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02083146
- Acronym / sponsor ID
- CAD(CTRP)
- Conditions
- Coronary Artery Disease (CAD)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study subjects were not enrolled.
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Mar 2014 (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.
Now, adipose tissue is established as an active endocrine organ that controls systemic energy homeostasis by secretion of adipokines. Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been reported to share structural homology with adiponectin. To date, 15 CTRP family members have been found that might play major roles in metabolism and inflammation. The investigators tried to clarify the relationship between CTRP family and coronary artery disease (CAD) in Korean men and women.
Detailed description
Adipose tissue secretes various kinds of bioactive molecules termed adipokines which contribute to the development of obesity-related disorders including cardiovascular disease (CVD). Adiponectin is the insulin-sensitizing adipokine with anti-inflammatory and anti-atherogenic properties. Hypoadiponectinemia has been associated with an increased risk of coronary artery disease (CAD) in several though not all studies. Recently, a new family of secreted proteins, C1q/TNF-related protein (CTRP), was cloned on the basis of sequence homology with adiponectin. This family of adiponectin paralogs might have pivotal implications in energy homeostasis and obesity-related inflammation. Each CTRP family member has its own unique tissue expression profile and function in regulating glucose and/or fat metabolism. In the present study, we evaluated the role of CTRP in patients with CAD and investigated whether CTRP family is significantly associated with CAD prevalence after adjustment for well-known CAD risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CAD | – | –Acute coronary syndromoe (ACS) patients who were admitted to the coronary care unit. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects with stable angina or a history of acute coronary syndrome who visited for a department of cardiology in Korea Univ. Guro hospital were enrolled using predefined inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- 20<age<80
- History of stable angina, unstable angina, or acute myocardial infarction
Key exclusion criteria (4 listed)
- a history of diabetes
- stage 2 hypertension
- malignancy
- severe renal or hepatic disease
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
serum concentration of CTRP-1,3, or 9 in the subjects with/without CAD
Time frame: at enrollment
compare serum concentration of CTRP-1,3 or 9 between CAD patients and normal group
1 secondary outcome
The relationships of serum CTRPs/adiponectin levels with cardiometabolic risk profiles
Time frame: at enrollment
Results and safety
The study was stopped early (reason given: Study subjects were not enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
Related trials for Coronary Artery Disease (CAD)
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
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.
Kyung Mook Choi, M.D. principal investigator
medica7@gmail.com
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 Coronary Artery Disease (CAD), run by Korea 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Mar 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?
The study was stopped early (reason given: Study subjects were not enrolled.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum concentration of CTRP-1,3, or 9 in the subjects with/without CAD (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2018.