NCT05106530

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

October 1, 2021

Last Update Submit

October 30, 2021

Conditions

Keywords

Coronary artery ectasia

Outcome Measures

Primary Outcomes (1)

  • Precence of arrhythmias in 24 hours Holter monitoring

    Incidence of arrhythmias in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.

    1 year

Secondary Outcomes (2)

  • • Heart rate variability in Holter monitoring

    1 year

  • • Silent ischemia as detected by Holter

    1 years

Study Arms (2)

Coronary Artery Ectasia patients

Diagnostic Test: Holter, ECG

Normal coronary artery patients

Diagnostic Test: Holter, ECG

Interventions

Holter, ECGDIAGNOSTIC_TEST

Incidence of arrhythmias in Holter monitoring among coronary artery ectasia patients as compared to normal coronary artery patients.

Coronary Artery Ectasia patientsNormal coronary artery patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.
  • Patients with severe renal impairment
  • Post CABG patients
  • Patients of acute coronary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Assiut University

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Coronary Aneurysm

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesAneurysmVascular Diseases

Intervention Hierarchy (Ancestors)

ElectrocardiographyHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Tarek Abd El Hameed, Assistant Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark M N Kamel, Resident

CONTACT

Hamdy Shams El Deen, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Cardiology Department

Study Record Dates

First Submitted

October 1, 2021

First Posted

November 3, 2021

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

November 3, 2021

Record last verified: 2021-10

Locations