Arrhythmogenic Risk Assessment in Coronary Artery Ectasia Patients

October 30, 2021 updated by: Mark Mohsen Nady Kamel, Assiut University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • faculty of medicine Assiut university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will include consecutive eligible patients recruited in Assiut University Heart Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary Artery Ectasia patients
Diagnostic test: Holter, ECG
Incidence of arrhythmias in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.
Normal coronary artery patients
Diagnostic test: Holter, ECG
Incidence of arrhythmias in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Precence of arrhythmias in 24 hours Holter monitoring
Time Frame: 1 year
Incidence of arrhythmias in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Heart rate variability in Holter monitoring
Time Frame: 1 year
Heart rate variability in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.
1 year
• Silent ischemia as detected by Holter
Time Frame: 1 years
Presence pf ischemia in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Tarek Abd El Hameed, Assistant Professor, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

October 1, 2021

First Submitted That Met QC Criteria

October 30, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 30, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arrhythmias in CAE patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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