Coronary AtherosclerosisNCT03322332
Adipokines of Epicardial Adipose Tissue and Atherosclerosis of Coronary Arteries
An observational study of Coronary Atherosclerosis and Adipokines, run by University Hospital, Ioannina at 1 site in Greece.
Trial summary
The aim of the study is to investigate whether the expression and production of adipokines secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Atherosclerosis, Adipokines
- How many people
- 160 participants
- Where
- 1 siteGreece
- Study dates
- 23 Oct 2017to 22 Jan 2018
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals undergoing cardiac surgery will be recruited in this study.
Who may be able to join
- 1) Individuals undergoing cardiac surgery
Who cannot join
- Age < 18 years
- HbA1c > 7.0%
- Any change of antidiabetic medication the previous 3 months before the surgery
- GFR < 60 mL/min/1.73 m2
- Liver disease
- Cancer
Show all 12Show fewer
- Non-treated hyperthyroidism or hypothyroidism
- Autoimmune disease
- Infection
- Any change in body weight at least 5% the previous 3 months before surgery
- Significant dehydration.
- Taking any of the following drugs the previous 3 months before surgery: hormones, antiobesity drugs
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Ioannina
Ioannina
Vasiliki Kyrouli, 0030 2651099519
About this study
Official title: The Role of Adipokines Secreted by Epicardial Adipose Tissue in the Atherosclerosis of Coronary Arteries
The aim of the study is to investigate whether the expression and production of adipokines secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis.
Read the detailed description
The aim of the study is to investigate whether the expression and production of four adipokines [adiponectin, omenin-1, resistin and retinol binding protein-4 (RBP4)] secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis. Specifically, this study aims to investigate whether the expression and production of these adipokines is different between two sites of the heart, that are perfused by coronary arteries with different degrees of stenosis.
- Conditions
- Coronary Atherosclerosis, Adipokines
- Keywords
- adiponectin, omentin-1, resistin, RBP4, epicardial fat, 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 |
|---|---|---|
| NonDM-0 | Nondiabetics without significant stenoses (> 50%) in the coronary arteries | |
| NonDM-L | Nondiabetics with significant stenosis in the left anterior descending (LAD) coronary artery or in the Left main (LM) coronary artery, but without significant stenosis in the right coronary artery (RCA) | |
| NonDM-R | Nondiabetics without significant stenosis in the LAD and in the LM, but with significant stenosis in the RCA | |
| NonDM-LR | Nondiabetics with significant stenosis in the LAD or in the LM and with significant stenosis in the RCA | |
| DM-0 | Patients with type 2 diabetes mellitus (T2DM) without significant stenoses in the coronary arteries | |
| DM-L | T2DM patients with significant stenosis in the LAD or in the LM, but without significant stenosis in RCA | |
| DM-R | T2DM patients without significant stenosis in the LAD and in the LM, but with significant stenosis in the RCA | |
| DM-LR | T2DM patients with significant stenosis in the LAD or in the LM and with significant stenosis in the RCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between coronary artery disease and epicardial adipokines
Comparison of the mRNA and protein production of four adipokines [adiponectin, omentin-1, resistin, retinol binding protein-4(RBP4)] from the epicardial adipose tissue between the territories that are supplied by LAD and RCA. This comparison will be performed in the following clusters of groups:
- Cluster 1: NonDM-0 and DM-0 (comparison between territories that are supplied by non-stenosed coronary arteries)
- Cluster 2: NonDM-LR and DM-LR (comparison between territories that are supplied by stenosed coronary arteries)
- Cluster 3: NonDM-L, NonDM-R, DM-L and DM-R (comparison between a territory that is supplied by stenosed coronary artery and another territory that is supplied by non-stenosed coronary artery)
Measured: Baseline measurement
Secondary outcomes (1)
Impact of diabetes on epicardial adipokines
Comparison of the mRNA and protein production of four adipokines (adiponectin, omentin-1, resistin, RBP4) from the epicardial adipose tissue of the territory that is supplied by LAD or RCA between the following groups:
- NonDM-0 vs DM-0
- NonDM-L vs DM-L
- NonDM-R vs DM-R
- NonDM-LR vs DM-LR
Measured: Baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start23 Oct 2017
- Primary completion15 Jan 2018 (estimated)
- Study completion22 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios A. Christou, University Hospital, Ioannina
- Investigators
- Eustratios Apostolakis, Professor, Study director, University Hospital, Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322332
- Sponsor's protocol ID
- 741
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Adipokines Secreted by Epicardial Adipose Tissue in the Atherosclerosis of Coronary Arteries
- ClinicalTrials.gov ID
- NCT03322332
- Acronym / sponsor ID
- 741
- Conditions
- Coronary Atherosclerosis, Adipokines
- Keywords
- adiponectin, omentin-1, resistin, RBP4, epicardial fat, Coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, IoanninaUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 15 Jan 2018 (estimated)
- Study completion
- 22 Jan 2018 (estimated)
- First posted
- 26 Oct 2017 (actual)
- 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.
The aim of the study is to investigate whether the expression and production of adipokines secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis.
Detailed description
The aim of the study is to investigate whether the expression and production of four adipokines [adiponectin, omenin-1, resistin and retinol binding protein-4 (RBP4)] secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis. Specifically, this study aims to investigate whether the expression and production of these adipokines is different between two sites of the heart, that are perfused by coronary arteries with different degrees of stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| NonDM-0 | – | –Nondiabetics without significant stenoses (> 50%) in the coronary arteries |
| NonDM-L | – | –Nondiabetics with significant stenosis in the left anterior descending (LAD) coronary artery or in the Left main (LM) coronary artery, but without significant stenosis in the right coronary artery (RCA) |
| NonDM-R | – | –Nondiabetics without significant stenosis in the LAD and in the LM, but with significant stenosis in the RCA |
| NonDM-LR | – | –Nondiabetics with significant stenosis in the LAD or in the LM and with significant stenosis in the RCA |
| DM-0 | – | –Patients with type 2 diabetes mellitus (T2DM) without significant stenoses in the coronary arteries |
| DM-L | – | –T2DM patients with significant stenosis in the LAD or in the LM, but without significant stenosis in RCA |
| DM-R | – | –T2DM patients without significant stenosis in the LAD and in the LM, but with significant stenosis in the RCA |
| DM-LR | – | –T2DM patients with significant stenosis in the LAD or in the LM and with significant stenosis in the RCA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals undergoing cardiac surgery will be recruited in this study.
Key inclusion criteria (1 listed)
- 1) Individuals undergoing cardiac surgery
Key exclusion criteria (12 listed)
- Age < 18 years
- HbA1c > 7.0%
- Any change of antidiabetic medication the previous 3 months before the surgery
- GFR < 60 mL/min/1.73 m2
- Liver 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
Association between coronary artery disease and epicardial adipokines
Time frame: Baseline measurement
Comparison of the mRNA and protein production of four adipokines [adiponectin, omentin-1, resistin, retinol binding protein-4(RBP4)] from the epicardial adipose tissue between the territories that are supplied by LAD and RCA. This comparison will be performed in the following clusters of groups: 1. Cluster 1: NonDM-0 and DM-0 (comparison between territories that are supplied by non-stenosed coronary arteries) 2. Cluster 2: NonDM-LR and DM-LR (comparison between territories that are supplied by stenosed coronary arteries) 3. Cluster 3: NonDM-L, NonDM-R, DM-L and DM-R (comparison between a territory that is supplied by stenosed coronary artery and another territory that is supplied by non-stenosed coronary artery)
1 secondary outcome
Impact of diabetes on epicardial adipokines
Time frame: Baseline measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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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.
Eustratios Apostolakis, Professor study director
University Hospital, Ioannina
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 Atherosclerosis and Adipokines, run by University Hospital, Ioannina at 1 site in Greece.
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 1 inclusion and 12 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 26 Oct 2017. 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 Greece. 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 Eustratios Apostolakis, Professor (0030 2651099679, stratisapostolakis@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between coronary artery disease and epicardial adipokines (time frame: Baseline measurement). 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 26 Oct 2017.