Electrocardiographic and Cardiac Magnetic Resonance Predictors of Ventricular Arrhythmias in Cardiomyopathic Patients

January 23, 2022 updated by: Khaled Mohamed Aly, Assiut University

ECG and CMR for Predicting PVCs in Cardiomyopathic Patients

This study aims to assess ECG changes for predicting ventricular arrhythmia in cardiomyopathic patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to assess ECG markers based on 24-hour Holter ECG recordings for predicting ventricular arrhythmia in patients with Structural Heart disease who have left ventricular dysfunction and Left Ventricular Ejection Fraction ≤40%. With special concerns to underlying structural abnormalities in cardiomyopathic patients using Cardiac Magnetic Resonance to determine ventricular function, scar distribution, and grey zone analysis

Study Type

Observational

Enrollment (Anticipated)

79

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study is anticipated to include all consecutive eligible cardiomyopathic patients.

Description

Inclusion Criteria:

  • Patients with ischemic and non-ischemic cardiomyopathy, EF < 40 %
  • Patient haemodynamically stable
  • Patients accept to make test

Exclusion Criteria:

  1. Patients with underlying arrhythmia ex heart block or atrial arrhythmia like PACs, AF.
  2. Patients on arrhythmogenic drugs ex digitalis, amiodarone.
  3. Patients on underlying Pacemaker device or CRT-D.
  4. Patients with MI in less than 40 days
  5. Patients refuse to make test .

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-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Twenty-four hours Holter monitoring after Magnetic Resonance Imaging
Time Frame: One year
24 Holter monitoring to detect PVCs burden which is defined as ≥10% of total beats
One year

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

March 30, 2023

Study Registration Dates

First Submitted

October 2, 2021

First Submitted That Met QC Criteria

October 2, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 23, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutU KMAly

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

Yes

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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