Jordanian Coronary Artery Ectasia Registry

Coronary Artery Ectasia Clinical Trial

— JoCAER  

Official title:

Jordanian Coronary Artery Ectasia Registry ,Incidence , Management and One Year Prognosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05213429
• Other study ID #: ICIGjordan
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2022
• Source: Interventional Cardiovascular Innovation Group, Jordan
• Contact: Mahmoud I Izraiq, MD,FACC
• Phone: 00962795652260
• Email: izraiq[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research project is the first in Jordan providing detailed registration of coronary ectasia cases provided by their primary healthcare providers. The investigators responsible for conducting this research are physicians and their teams who deal with patients with coronary ectasia in their clinics including the public and private medical sectors in Jordan's' medical community. Standards in Jordan complies with the recognized guidelines directed medical practices internationally.

Description:

Coronary artery ectasia (CAE) is the diffuse dilatation of coronary artery. It is defined as a dilatation with a diameter of 1.5 times the adjacent normal coronary artery. Its prevalence ranges from 1.2%-4.9% with male to female ratio of 3:1 .

Coronary ectasia likely represents an exaggerated form of expansive vascular remodeling (i.e. excessive expansive remodeling) in response to atherosclerotic plaque growth .

CAE is more common in males. Hypertension is a risk Factor. Interestingly, patients with DM have low incidence of CAE. This may be due to down regulation of MMP with negative remodeling in response to atherosclerosis . Smoking appears to be more common in patients with CAE than in those with coronary artery disease (CAD).

The angiographic classification for CAE (described by Markis et al.) categorizes the severity based on the extent of coronary arterial involvement: Type 1: Diffuse ectasia of 2-3 arteries; Type 2: Diffuse ectasia in one artery and localized in another; Type 3: Diffuse single arterial ectasia; Type 4: Localized or segmental ectasia.

Stable angina is the most common presentation in patients with CAE . Patients with CAE without stenosis had positive results during treadmill exercise tests. ST-elevation myocardial infarction (MI) , non-ST elevation MI can occur from altered blood flow by distal embolization or occlusion of ectatic segment with thrombus.

Medical management for CAE is a controversial area as there is lack of evidence based medicine, especially the role of antiplatelet versus anticoagulant agents. Aspirin was suggested in all patients because of coexistence of CAE with obstructive coronary lesions in the great majority of patients and the observed incidence of myocardial infarction, even in patients with isolated coronary ectasia .The role of dual anti platelet therapy has not been evaluated in prospective randomized studies. Based on the significant flow disturbances within the ecstatic segments, chronic anticoagulation with warfarin as main therapy was suggested

this study aims to fill the existing gap in the cardiac community about the topic of coronary ectasia. There is a substantial lack of dependable scientific data regarding the prevalence and disease prognosis of coronary ectasia. Screening, management and follow-up of coronary ectasia patients combined with comparative tests with reference studies will be initiated. A direct impact on improving coronary ectasia prognostic outcomes is expected by focusing efforts on determining the prevalence, prognosis and management procedures of ectasia. collected data will aid in improving the current therapeutic approaches to coronary ectasia and providing better control and management of coronary ectasia cases in Jordan.

Study objectives:

Taking into account the classical coronary ectasia definition, the investigators propose:

• ANATOMIC OBJECTIVES.

• To characterize coronary ectasia prevalence causing invasive coronary angiography.

• To describe anatomy, location and aneurysms features.

• To assess intracoronary imaging data if available.

• To determine the underlying causes of coronary ectasia in patients

• CLINICAL OBJECTIVES.

• Determine the cause for the diagnostic catheterization and ectasia symptoms, if present.

• Patient´s clinical features.

• Long-term outcomes.

• THERAPEUTIC OBJECTIVES.

• To assess management strategies (conservative, interventional or surgical) and its short and long term results.

• Disease management outcomes .

Study design Study Type : Observational [Patient Registry] Actual Enrollment : 10,000 participants Observational Model: Cohort Time Perspective: prospective

Target Follow-Up Duration: 2 years

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with suspected CAD who are referred for elective coronary angiography and fit the Coronary ectasia definition.

Exclusion Criteria:

• Patient younger than 18 years old.

• Patients who refuse to sign a consent form . Patients who are enrolled in another Ectasia study

Related Conditions & MeSH terms

• Coronary Aneurysm
• Coronary Artery Ectasia

Intervention

Other:
• non interventional study
non interventional

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Interventional Cardiovascular Innovation Group, Jordan

References & Publications (3)

Devabhaktuni S, Mercedes A, Diep J, Ahsan C. Coronary Artery Ectasia-A Review of Current Literature. Curr Cardiol Rev. 2016;12(4):318-323. Review. — View Citation

Hartnell GG, Parnell BM, Pridie RB. Coronary artery ectasia. Its prevalence and clinical significance in 4993 patients. Br Heart J. 1985 Oct;54(4):392-5. — View Citation

Willner NA, Ehrenberg S, Musallam A, Roguin A. Coronary artery ectasia: prevalence, angiographic characteristics and clinical outcome. Open Heart. 2020 Apr;7(1). pii: e001096. doi: 10.1136/openhrt-2019-001096. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events	MI, stroke, angina and hospitalization	1 year
Secondary	all cause of death	CV death , Non-CV death	1 year