Jordanian Coronary Artery Ectasia Registry (JoCAER)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Ectasia
• Intervention / Treatment: Other: non interventional study

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Mahmoud I Izraiq, MD,FACC; Phone Number: 00962795652260; Email: izraiq@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with a coronary Ectasia diagnosis after PCI imaging

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular events	MI, stroke, angina and hospitalization	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all cause of death	CV death , Non-CV death	1 year

Collaborators and Investigators

• Sponsor: Interventional Cardiovascular Innovation Group, Jordan
• Investigators: Study Chair: Mahmoud I Izraiq, MD,FACC, Interventional Cardiovascular Innovation Group, Jordan

Publications and helpful links

General Publications

• Devabhaktuni S, Mercedes A, Diep J, Ahsan C. Coronary Artery Ectasia-A Review of Current Literature. Curr Cardiol Rev. 2016;12(4):318-323. doi: 10.2174/1573403x12666160504100159.
• 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. doi: 10.1136/hrt.54.4.392.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Coronary Disease; Aneurysm; Dilatation, Pathologic; Coronary Aneurysm
• Other Study ID Numbers: ICIGjordan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No