Coronary Artery DiseaseNCT01869816
CTRP3 and Progranulin in Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Korea University at 1 site in South Korea.
Trial summary
Visceral obesity is the one of the major causes of cardiovascular morbidity and mortality in industrialized countries. Adipose tissue secretes various kinds of bioactive molecules termed adipokines which contribute to the development of obesity-related disorders including cardiovascular disease (CVD). 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
- How many people
- 362 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2011to 31 Dec 2012
- 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: Acute coronary syndrome (ACS) patients, who were admitted to the coronary care units of the Division of Cardiology at Guro Hospital in Korea University Medical Center. Control subjects were recruited from the participants for a routine health check-up in the Health Promotion Center of Korea University Guro Hospital.
Who may be able to join
- acute myocardial infarction
- unstable angina
- stable angina pectoris
Who cannot join
- For control group, we exclude the participants who had
- a history of CVD (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- type 2 diabetes
- stage 2 hypertension (resting blood pressure, ≥160/100 mmHg)
- malignancy
- severe renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Guro Hospital Dept. of Endocrinology
Seoul
About this study
Official title: Implications of C1q/TNF-related Protein-3(CTRP-3) and Progranulin in Patients With Acutecoronary Syndrome and Stable Angina Pectoris
Visceral obesity is the one of the major causes of cardiovascular morbidity and mortality in industrialized countries. Adipose tissue secretes various kinds of bioactive molecules termed adipokines which contribute to the development of obesity-related disorders including cardiovascular disease (CVD). Progranulin and CTRP3 are recently discovered novel adipokines. Therefore, the investigators tried to compare circulating CTRP-3 and progranulin levels in patients with CAD and investigated whether CTRP-3 or progranulin is significantly associated with CAD prevalence after adjustment for well-known CAD risk factors.
Read the detailed description
CTRP-3 (synonyms CORS-26, cartducin and cartonectin) is a potent anti-inflammatory adipokine that inhibits proinflammatory pathways in monocytes and adipocytes. Using a recently developed enzymelinked immunosorbent assay (ELISA), we reported that circulating CTRP-3 levels were elevated in patients with glucose metabolism dysregulation.
Progranulin was identified as a key adipokine mediating high fat diet-induced insulin resistance and obesity through interleukin-6 (IL-6) in adipose tissue. We previously reported that progranulin levels were significantly higher in individuals with type 2 diabetes and were associated with macrophage infiltration in omental adipose tissue. Moreover, the expression of progranulin reduces inflammation and its degradation into granulins peptides enhances inflammation in atherosclerotic plaque, which may contribute to the progression of atherosclerosis There has been no previous report on the implication of CTRP-3 or progranulin in humans with cardiovascular disease (CAD). In the present study, we compared circulating CTRP-3 and progranulin levels in patients with CAD and investigated whether CTRP-3 or progranulin is significantly associated with CAD prevalence after adjustment for well known CAD risk factors.
- Conditions
- Coronary Artery Disease
- Keywords
- CTRP-3, progranulin, coronary artery disease
- 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 |
|---|---|---|
| Acute coronary syndrome (ACS) | Who were admitted to the coronary care units of the division of cardiology at Guro hospital in Korea University Medical Center. They have Acute myocardial infarction or unstable angina. | |
| Stable angina pectoris (SAP) | Who were admitted to the coronary care units of the division of cardiology at Guro hospital in Korea University Medical Center. They have Stable angina. | |
| Control | Who were recruited from the participants for a routine health check-up in the Health Promotion Center of Korea University Guro Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTRP3
CTRP3 (ng/ml)
Measured: 16 months
Secondary outcomes (4)
SBP
SBP (mmHg)
Measured: 16 months
LDL cholesterol
LDL (mg/dl)
Measured: 16 months
hsCRP
hsCRP (mg/dl)
Measured: 16 months
creatinine
creatinine (mg/dl)
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study start1 Mar 2011
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Cohort
- 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, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869816
- Sponsor's protocol ID
- CAD(CTRP3,PRGL)
- Status last verified
- Aug 2020
- First submitted
- 2 Jun 2013
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of C1q/TNF-related Protein-3(CTRP-3) and Progranulin in Patients With Acutecoronary Syndrome and Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT01869816
- Acronym / sponsor ID
- CAD(CTRP3,PRGL)
- Conditions
- Coronary Artery Disease
- Keywords
- CTRP-3, progranulin, coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- 1 Mar 2011
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 5 Jun 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.
Visceral obesity is the one of the major causes of cardiovascular morbidity and mortality in industrialized countries. Adipose tissue secretes various kinds of bioactive molecules termed adipokines which contribute to the development of obesity-related disorders including cardiovascular disease (CVD). Progranulin and CTRP3 are recently discovered novel adipokines. Therefore, the investigators tried to compare circulating CTRP-3 and progranulin levels in patients with CAD and investigated whether CTRP-3 or progranulin is significantly associated with CAD prevalence after adjustment for well-known CAD risk factors.
Detailed description
CTRP-3 (synonyms CORS-26, cartducin and cartonectin) is a potent anti-inflammatory adipokine that inhibits proinflammatory pathways in monocytes and adipocytes. Using a recently developed enzymelinked immunosorbent assay (ELISA), we reported that circulating CTRP-3 levels were elevated in patients with glucose metabolism dysregulation.
Progranulin was identified as a key adipokine mediating high fat diet-induced insulin resistance and obesity through interleukin-6 (IL-6) in adipose tissue. We previously reported that progranulin levels were significantly higher in individuals with type 2 diabetes and were associated with macrophage infiltration in omental adipose tissue. Moreover, the expression of progranulin reduces inflammation and its degradation into granulins peptides enhances inflammation in atherosclerotic plaque, which may contribute to the progression of atherosclerosis There has been no previous report on the implication of CTRP-3 or progranulin in humans with cardiovascular disease (CAD). In the present study, we compared circulating CTRP-3 and progranulin levels in patients with CAD and investigated whether CTRP-3 or progranulin is significantly associated with CAD prevalence after adjustment for well known CAD risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute coronary syndrome (ACS) | – | –Who were admitted to the coronary care units of the division of cardiology at Guro hospital in Korea University Medical Center. They have Acute myocardial infarction or unstable angina. |
| Stable angina pectoris (SAP) | – | –Who were admitted to the coronary care units of the division of cardiology at Guro hospital in Korea University Medical Center. They have Stable angina. |
| Control | – | –Who were recruited from the participants for a routine health check-up in the Health Promotion Center of Korea University Guro Hospital. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute coronary syndrome (ACS) patients, who were admitted to the coronary care units of the Division of Cardiology at Guro Hospital in Korea University Medical Center. Control subjects were recruited from the participants for a routine health check-up in the Health Promotion Center of Korea University Guro Hospital.
Key inclusion criteria (3 listed)
- acute myocardial infarction
- unstable angina
- stable angina pectoris
Key exclusion criteria (6 listed)
- For control group, we exclude the participants who had
- a history of CVD (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- type 2 diabetes
- stage 2 hypertension (resting blood pressure, ≥160/100 mmHg)
- malignancy
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
CTRP3
Time frame: 16 months
CTRP3 (ng/ml)
4 secondary outcomes
SBP
Time frame: 16 months
LDL cholesterol
Time frame: 16 months
hsCRP
Time frame: 16 months
creatinine
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
Kyung Mook Choi, M.D. principal investigator
Korea University
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, 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 2 Sep 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CTRP3 (time frame: 16 months). 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 2 Sep 2020.