Patients Undergoing Coronary AngiographyNCT01585948
Study of the Effect of Diabetes on the Incidence and the Extent of Coronary Artery Disease
An observational study of Patients Undergoing Coronary Angiography, run by University of Ioannina at 1 site in Greece.
Trial summary
In the present study the investigators will measure the extent of coronary artery disease via coronary angiography and the correlating risk factors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patients Undergoing Coronary Angiography
- How many people
- 1,104 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2009to Mar 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetics and non-diabetics who are admitted in the Cardiology Department in the University Hospital of Ioannina and undergo coronary angiography for clinical purposes will be studied. The study will include subjects who have suspected stable CAD or an acute coronary syndrome and undergo a diagnostic angiography. Patients revascularized in the past (either coronary artery bypass grafting or percutaneous coronary intervention) will be excluded from the study since it is not possible to describe the extent of CAD in these patients. We plan to recruit about 1,000 patients in about 2 years in order for valid conclusions to be drawn from association analysis between CV risk factors, gene polymorphisms and the presence and extent of CAD.
Who may be able to join
- Any subject eligible for coronary angiography with or without known CV disease for clinical reasons.
Who cannot join
- Patients revascularized in the past, with either coronary artery bypass grafting or percutaneous coronary intervention, will be excluded from the study since it is not possible to describe the extent of CAD in these patients.
- Moderate or severe aortic stenosis.
Trial locations and contacts
1 site in 1 country.
Greece1 site
2nd Department of Cardiology, University Hospital of Ioannina
Ioannina, 45110
About this study
Official title: The Role of Newer and Traditional Risk Factors in the Development, Extent and Manifestation of Coronary Artery Disease
In the present study the investigators will measure the extent of coronary artery disease via coronary angiography and the correlating risk factors.
Read the detailed description
In the present study the investigators will examine the risk factors determining the development, extent and the manifestation of coronary artery disease. The study will recruit patients undergoing coronary angiography for clinical purposes.
- Conditions
- Patients Undergoing Coronary Angiography
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 |
|---|---|---|
| Diabetes Mellitus | All patients undergoing coronary angiography who are diabetics. | |
| No diabetes mellitus | All patients undergoing coronary angiography that are non-diabetics. | |
| Coronary angiography patients | Diabetics and non-diabetics with or without known CV disease who are admitted in the Department of Cardiology in the University Hospital of Ioannina and the Catheterization Laboratory of 1st IKA Hospital in Athens and undergo coronary angiography for clinical purposes will be studied. The study will include subjects who 1) have suspected CAD and undergo a scheduled diagnostic angiogram for clinical reasons, and 2) are hospitalized because of an acute coronary syndrome and thus undergo diagnostic angiography (with or without previous history of CAD). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and extent of coronary artery disease between diabetics and non-diabetic patients.
We will investigate the incidence, extent and clinical manifestation of coronary artery disease in diabetics and non-diabetics undergoing coronary angiography for clinical reasons.
Measured: Up to four years on average.
Secondary outcomes (3)
The incidence and extent of coronary artery disease via coronary angiography scores and related biochemical and demographical risk factors.
To associate the incidence, extent and clinical manifestation of coronary artery disease with classic demographic risk factors (such as smoking, alcohol consumption, physical exercise, arterial hypertension, family history of diabetes mellitus or coronary artery disease) and common biochemical risk factors (such as fasting glucose levels, urea, creatinine, HbA1c%, uric acid, total cholesterol, HDL, LDL, triglycerides, VLDL, glomerular filtration rate - GFR).
Measured: Up to 4 years on average.
The incidence, extent and clinical manifestation of coronary artery disease and the circulating levels of hs-CRP, adipokines and RAGEs.
To associate the incidence, extent and clinical manifestation of coronary artery disease with systemic inflammatory status assessed by hs-CRP levels, circulating adipokines (adiponectin, resistin) and the receptors of advanced glycation end products (sRAGE and esRAGE).
Measured: Up to 4 years on average.
TCF7L2 gene polymorphims and the incidence and extent of coronary artery disease.
To associate the incidence, extent and clinical manifestation of coronary artery disease with the rs7903146 single nucleotide polymorphism of TCF7L2 gene, that has been strongly associated with diabetes mellitus development.
Measured: Within a maximum period of 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startNov 2009
- Primary completionMay 2013
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Coronary AngiographyStudies 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
- 1,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ioannina, Catheterization Laboratory of 1st IKA Hospital, Athens
- Responsible party
- Principal investigator, MICHALIS LAMPROS, University of Ioannina
- Investigators
- Katerina Naka, As Professor, Principal investigator, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585948
- Sponsor's protocol ID
- UOICAD2010
- Status last verified
- Mar 2020
- First submitted
- 16 Aug 2011
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Newer and Traditional Risk Factors in the Development, Extent and Manifestation of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01585948
- Acronym / sponsor ID
- UOICAD2010
- Conditions
- Patients Undergoing Coronary Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,104 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Collaborators
- University Hospital, Ioannina, Catheterization Laboratory of 1st IKA Hospital, Athens
- Study start
- Nov 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 26 Apr 2012 (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.
In the present study the investigators will measure the extent of coronary artery disease via coronary angiography and the correlating risk factors.
Detailed description
In the present study the investigators will examine the risk factors determining the development, extent and the manifestation of coronary artery disease. The study will recruit patients undergoing coronary angiography for clinical purposes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus | – | –All patients undergoing coronary angiography who are diabetics. |
| No diabetes mellitus | – | –All patients undergoing coronary angiography that are non-diabetics. |
| Coronary angiography patients | – | –Diabetics and non-diabetics with or without known CV disease who are admitted in the Department of Cardiology in the University Hospital of Ioannina and the Catheterization Laboratory of 1st IKA Hospital in Athens and undergo coronary angiography for clinical purposes will be studied. The study will include subjects who 1) have suspected CAD and undergo a scheduled diagnostic angiogram for clinical reasons, and 2) are hospitalized because of an acute coronary syndrome and thus undergo diagnostic angiography (with or without previous history of CAD). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetics and non-diabetics who are admitted in the Cardiology Department in the University Hospital of Ioannina and undergo coronary angiography for clinical purposes will be studied. The study will include subjects who have suspected stable CAD or an acute coronary syndrome and undergo a diagnostic angiography. Patients revascularized in the past (either coronary artery bypass grafting or percutaneous coronary intervention) will be excluded from the study since it is not possible to describe the extent of CAD in these patients. We plan to recruit about 1,000 patients in about 2 years in order for valid conclusions to be drawn from association analysis between CV risk factors, gene polymorphisms and the presence and extent of CAD.
Key inclusion criteria (1 listed)
- Any subject eligible for coronary angiography with or without known CV disease for clinical reasons.
Key exclusion criteria (2 listed)
- Patients revascularized in the past, with either coronary artery bypass grafting or percutaneous coronary intervention, will be excluded from the study since it is not possible to describe the extent of CAD in these patients.
- Moderate or severe aortic stenosis.
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
The incidence and extent of coronary artery disease between diabetics and non-diabetic patients.
Time frame: Up to four years on average.
We will investigate the incidence, extent and clinical manifestation of coronary artery disease in diabetics and non-diabetics undergoing coronary angiography for clinical reasons.
3 secondary outcomes
The incidence and extent of coronary artery disease via coronary angiography scores and related biochemical and demographical risk factors.
Time frame: Up to 4 years on average.
The incidence, extent and clinical manifestation of coronary artery disease and the circulating levels of hs-CRP, adipokines and RAGEs.
Time frame: Up to 4 years on average.
TCF7L2 gene polymorphims and the incidence and extent of coronary artery disease.
Time frame: Within a maximum period of 4 years.
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 26 Mar 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.
Katerina Naka, As Professor principal investigator
University of 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 Patients Undergoing Coronary Angiography, run by University of 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 2 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 26 Mar 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 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?
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?
The incidence and extent of coronary artery disease between diabetics and non-diabetic patients. (time frame: Up to four years on average.). 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 Mar 2020.