Coronary Artery DiseaseT-ICENCT05897333
Turkish Isolated Coronary Ectasia Registry: The T-ICE Registry
An observational study of Coronary Artery Disease, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The T-ICE study is a prospective, observational study aiming to have information about the treatment and long-term prognosis of patients with isolated coronary artery ectasia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 3,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 15 Mar 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients with "isolated" coronary ectasia in at least one coronary artery in their first coronary angiography performed for any reason will be included in the study.
Who may be able to join
- Isolated coronary artery ectasia (without ≥20% stenosis in any coronary artery ≥2 mm in diameter).
- All patients with isolated coronary ectasia with or without acute coronary syndrome will be included.
- Patients aged ≥18 years.
- Patients with discrete coronary artery aneurysm will be included.
Who cannot join
- Life expectancy <24 months
- Patients with ≥20% stenosis in a vessel ≥2 mm in diameter.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University, School of Medicine
Ankara, 06550
Adnan Abaci, 03122025631, abaci@gazi.edu.tr
About this study
Official title: Turkish Isolated Coronary Ectasia Prospective Cohort Study: the T-ICE Registry
The T-ICE study is a prospective, observational study aiming to have information about the treatment and long-term prognosis of patients with isolated coronary artery ectasia.
Read the detailed description
Coronary artery ectasia is a localized or diffuse enlargement of the coronary artery lumen ≥1.5-2 times relative to the normal segment. It is often associated with coronary artery stenosis. Some patients have coronary artery ectasia without stenosis. This condition is called as isolated coronary artery ectasia. There is data other than retrospective studies with a small number of cases on the clinical significance, prognosis and treatment of isolated coronary ectasia in patients with or without acute coronary syndrome. Therefore, the treatment of patients with isolated coronary ectasia is not evidence-based and is based on the clinical judgment of physicians. The aim of this prospective observational study is to evaluate the treatment and prognosis of the isolated coronary artery ectasia. The second aim is to compare the prognosis of isolated coronary ectasia with the coronary artery disease.
- Conditions
- 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 |
|---|---|---|
| Isolated coronary ectasia | Includes the patients with isolated coronary artery ectasia without coronary stenosis. | |
| Coronary artery disease | Includes the patients with ≥50% stenosis in a vessel ≥2 mm in diameter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and cerebrovascular events
A composite endpoint of death, myocardial infarction, unstable angina, stroke, and coronary revascularization.
Measured: Five years
Secondary outcomes (1)
Major adverse cardiovascular events
A composite endpoint of cardiovascular death, myocardial infarction, unstable angina, and coronary revascularization.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start15 Mar 2022
- Primary completion15 Mar 2032 (estimated)
- Study completion15 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Abacı, MD, Gazi University
- Investigators
- Adnan Abaci, Principal investigator, Gazi University, School of Medicine, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897333
- Sponsor's protocol ID
- 03063806
- Acronym
- T-ICE
- Status last verified
- May 2023
- First submitted
- 22 Feb 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manginas A, Cokkinos DV. Coronary artery ectasias: imaging, functional assessment and clinical implications. Eur Heart J. 2006 May;27(9):1026-31. doi: 10.1093/eurheartj/ehi725. Epub 2006 Jan 16.
PubMed 16415301Baman TS, Cole JH, Devireddy CM, Sperling LS. Risk factors and outcomes in patients with coronary artery aneurysms. Am J Cardiol. 2004 Jun 15;93(12):1549-51. doi: 10.1016/j.amjcard.2004.03.011.
PubMed 15194034Malviya A, Jha PK, Mishra A. Isolated coronary artery ectasia: Clinical, angiographic, and follow up characteristics. Indian Heart J. 2017 Sep-Oct;69(5):619-623. doi: 10.1016/j.ihj.2016.12.017. Epub 2017 Jan 22.
PubMed 29054186Erden I, Erden EC, Ozhan H, Karabulut A, Ordu S, Yazici M. Outcome of primary percutaneous intervention in patients with infarct-related coronary artery ectasia. Angiology. 2010 Aug;61(6):574-9. doi: 10.1177/0003319709361197. Epub 2010 Apr 14.
PubMed 20395236Vasu N, Narayanan S, Ajit MS. Clinical outcome of various management strategies in coronary artery ectasia. Indian Heart J. 2017 May-Jun;69(3):319-321. doi: 10.1016/j.ihj.2017.04.013. Epub 2017 May 4. No abstract available.
PubMed 28648421Boles U, Zhao Y, Rakhit R, Shiu MF, Papachristidis A, David S, Koganti S, Gilbert T, Henein MY. Patterns of coronary artery ectasia and short-term outcome in acute myocardial infarction. Scand Cardiovasc J. 2014 Jun;48(3):161-6. doi: 10.3109/14017431.2014.902495. Epub 2014 Apr 10.
PubMed 24673382Willner NA, Ehrenberg S, Musallam A, Roguin A. Coronary artery ectasia: prevalence, angiographic characteristics and clinical outcome. Open Heart. 2020 Apr;7(1):e001096. doi: 10.1136/openhrt-2019-001096.
PubMed 32515749
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Isolated Coronary Ectasia Prospective Cohort Study: the T-ICE Registry
- ClinicalTrials.gov ID
- NCT05897333
- Acronym / sponsor ID
- T-ICE / 03063806
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Mar 2032 (estimated)
- Study completion
- 15 Mar 2032 (estimated)
- First posted
- 9 Jun 2023 (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 T-ICE study is a prospective, observational study aiming to have information about the treatment and long-term prognosis of patients with isolated coronary artery ectasia.
Detailed description
Coronary artery ectasia is a localized or diffuse enlargement of the coronary artery lumen ≥1.5-2 times relative to the normal segment. It is often associated with coronary artery stenosis. Some patients have coronary artery ectasia without stenosis. This condition is called as isolated coronary artery ectasia. There is data other than retrospective studies with a small number of cases on the clinical significance, prognosis and treatment of isolated coronary ectasia in patients with or without acute coronary syndrome. Therefore, the treatment of patients with isolated coronary ectasia is not evidence-based and is based on the clinical judgment of physicians. The aim of this prospective observational study is to evaluate the treatment and prognosis of the isolated coronary artery ectasia. The second aim is to compare the prognosis of isolated coronary ectasia with the coronary artery disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated coronary ectasia | – | –Includes the patients with isolated coronary artery ectasia without coronary stenosis. |
| Coronary artery disease | – | –Includes the patients with ≥50% stenosis in a vessel ≥2 mm in diameter. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with "isolated" coronary ectasia in at least one coronary artery in their first coronary angiography performed for any reason will be included in the study.
Key inclusion criteria (4 listed)
- Isolated coronary artery ectasia (without ≥20% stenosis in any coronary artery ≥2 mm in diameter).
- All patients with isolated coronary ectasia with or without acute coronary syndrome will be included.
- Patients aged ≥18 years.
- Patients with discrete coronary artery aneurysm will be included.
Key exclusion criteria (2 listed)
- Life expectancy <24 months
- Patients with ≥20% stenosis in a vessel ≥2 mm in diameter.
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
Major adverse cardiovascular and cerebrovascular events
Time frame: Five years
A composite endpoint of death, myocardial infarction, unstable angina, stroke, and coronary revascularization.
1 secondary outcome
Major adverse cardiovascular events
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 16415301Manginas A, Cokkinos DV. Coronary artery ectasias: imaging, functional assessment and clinical implications. Eur Heart J. 2006 May;27(9):1026-31. doi: 10.1093/eurheartj/ehi725. Epub 2006 Jan 16.
- Background: PubMed 15194034Baman TS, Cole JH, Devireddy CM, Sperling LS. Risk factors and outcomes in patients with coronary artery aneurysms. Am J Cardiol. 2004 Jun 15;93(12):1549-51. doi: 10.1016/j.amjcard.2004.03.011.
- Background: PubMed 29054186Malviya A, Jha PK, Mishra A. Isolated coronary artery ectasia: Clinical, angiographic, and follow up characteristics. Indian Heart J. 2017 Sep-Oct;69(5):619-623. doi: 10.1016/j.ihj.2016.12.017. Epub 2017 Jan 22.
- Background: PubMed 20395236Erden I, Erden EC, Ozhan H, Karabulut A, Ordu S, Yazici M. Outcome of primary percutaneous intervention in patients with infarct-related coronary artery ectasia. Angiology. 2010 Aug;61(6):574-9. doi: 10.1177/0003319709361197. Epub 2010 Apr 14.
- Background: PubMed 28648421Vasu N, Narayanan S, Ajit MS. Clinical outcome of various management strategies in coronary artery ectasia. Indian Heart J. 2017 May-Jun;69(3):319-321. doi: 10.1016/j.ihj.2017.04.013. Epub 2017 May 4. No abstract available.
- Background: PubMed 24673382Boles U, Zhao Y, Rakhit R, Shiu MF, Papachristidis A, David S, Koganti S, Gilbert T, Henein MY. Patterns of coronary artery ectasia and short-term outcome in acute myocardial infarction. Scand Cardiovasc J. 2014 Jun;48(3):161-6. doi: 10.3109/14017431.2014.902495. Epub 2014 Apr 10.
- Background: PubMed 32515749Willner NA, Ehrenberg S, Musallam A, Roguin A. Coronary artery ectasia: prevalence, angiographic characteristics and clinical outcome. Open Heart. 2020 Apr;7(1):e001096. doi: 10.1136/openhrt-2019-001096.
- Individual participant dataSharing planned: No
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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.
Adnan Abaci principal investigator
Gazi University, School of Medicine, Department of Cardiology
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 Gazi University at 1 site in Turkey (Türkiye).
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 4 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: looking for participants now, as of the sponsor's last update on 9 Jun 2023. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adnan Abaci (+903122025631, abaci@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebrovascular events (time frame: Five years). 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 NCT05897333, which also lists 7 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 9 Jun 2023.