Turkish Isolated Coronary Ectasia Registry: The T-ICE Registry

NCT ID: NCT05897333

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-15

Study Completion Date

2032-03-15

Brief Summary

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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

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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

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Isolated coronary ectasia

Includes the patients with isolated coronary artery ectasia without coronary stenosis.

No interventions assigned to this group

Coronary artery disease

Includes the patients with ≥50% stenosis in a vessel ≥2 mm in diameter.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Life expectancy \<24 months
* Patients with ≥20% stenosis in a vessel ≥2 mm in diameter.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Adnan Abacı, MD

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adnan Abaci

Role: PRINCIPAL_INVESTIGATOR

Gazi University, School of Medicine, Department of Cardiology

Locations

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Gazi University, School of Medicine

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Adnan Abaci

Role: CONTACT

+903122025631

Emrullah Kızıltunc

Role: CONTACT

+903122025629

Facility Contacts

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Adnan Abaci

Role: primary

03122025631

References

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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.

Reference Type BACKGROUND
PMID: 16415301 (View on PubMed)

Baman 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.

Reference Type BACKGROUND
PMID: 15194034 (View on PubMed)

Malviya 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.

Reference Type BACKGROUND
PMID: 29054186 (View on PubMed)

Erden 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.

Reference Type BACKGROUND
PMID: 20395236 (View on PubMed)

Vasu 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.

Reference Type BACKGROUND
PMID: 28648421 (View on PubMed)

Boles 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.

Reference Type BACKGROUND
PMID: 24673382 (View on PubMed)

Willner 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.

Reference Type BACKGROUND
PMID: 32515749 (View on PubMed)

Other Identifiers

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03063806

Identifier Type: -

Identifier Source: org_study_id

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