NCT05897333

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Mar 2022Mar 2032

Study Start

First participant enrolled

March 15, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2032

Last Updated

June 9, 2023

Status Verified

May 1, 2023

Enrollment Period

10 years

First QC Date

February 22, 2023

Last Update Submit

May 31, 2023

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular and cerebrovascular events

    A composite endpoint of death, myocardial infarction, unstable angina, stroke, and coronary revascularization.

    Five years

Secondary Outcomes (1)

  • Major adverse cardiovascular events

    Five years

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Life expectancy \<24 months
  • Patients with ≥20% stenosis in a vessel ≥2 mm in diameter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, School of Medicine

Ankara, 06550, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • 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.

    PMID: 16415301BACKGROUND

  • 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.

    PMID: 15194034BACKGROUND

  • 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.

    PMID: 29054186BACKGROUND

  • 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.

    PMID: 20395236BACKGROUND

  • 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.

    PMID: 28648421BACKGROUND

  • 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.

    PMID: 24673382BACKGROUND

  • 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.

    PMID: 32515749BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Adnan Abaci

    Gazi University, School of Medicine, Department of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adnan Abaci

CONTACT

+903122025631abaci@gazi.edu.tr

Emrullah Kızıltunc

CONTACT

+903122025629e.kiziltunc@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 22, 2023

First Posted

June 9, 2023

Study Start

March 15, 2022

Primary Completion (Estimated)

March 15, 2032

Study Completion (Estimated)

March 15, 2032

Last Updated

June 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)