Arrhythmogenic Risk Assessment in Coronary Artery Ectasia Patients

• Conditions: Coronary Artery Ectasia
• Interventions: Diagnostic Test: Holter, ECG

• Registration Number: NCT05106530
• Lead Sponsor: Assiut University

Brief Summary

The investigators thought to explore arrhythmias outcome - hidden arrhythmias, ECG features: Tp-Te interval and Tp-Te/QTc ratio, fQRS among patients with coronary artery ectasia as compared to normal coronary artery patients.

Detailed Description

All patients will be subjected to:

A. Full history taking:

- Including age, sex, history of DM, HTN, dyslipidemia and Body surface area.

B. Holter monitoring for 24 hours:

* Heart rate variability

* Hidden arrhythmias

* Hidden ischemia by monitoring ST segment changes

C. Twelve lead ECG:

* fQRS in baseline ECG

* QT dispersion.

* Tp-Te interval and Tp-Te/QTc ratio

* Tp-Te dispersion

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-30
• Last Update Submitted: 2021-10-30
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-03
• Study Start: 2022-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Subjects with suspected CAD who are referred for elective coronary angiography and/or interventions

Exclusion Criteria

1. Patients with a history of cardiomyopathy and myocardial infarction (MI), left ventricular hypertrophy (LVH), pathological Q wave on ECG, typical left bundle block or right bundle block, incomplete right bundle block, or paced rhythm on ECG.
2. Patients with severe renal impairment
3. Post CABG patients
4. Patients of acute coronary syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Ectasia patients	Holter, ECG	-
Normal coronary artery patients	Holter, ECG	-

Primary Outcome Measures

Name	Time	Method
Precence of arrhythmias in 24 hours Holter monitoring	1 year	Incidence of arrhythmias in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.

Secondary Outcome Measures

Name	Time	Method
• Heart rate variability in Holter monitoring	1 year	Heart rate variability in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.
• Silent ischemia as detected by Holter	1 years	Presence pf ischemia in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.

Trial Locations

Locations (1)

Faculty of Medicine Assiut University; 🇪🇬 Assiut, Egypt