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

Premature Ventricular Complex Clinical Trial

Official title:

ECG and CMR for Predicting PVCs in Cardiomyopathic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05078125
• Other study ID #: AssiutU KMAly
• Status: Not yet recruiting
• Start date: April 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 79
• Est. completion date: March 30, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Premature Ventricular Complex
• Ventricular Premature Complexes

Intervention

Device:
• Holter monitoring
24 hours Holter monitoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Lee DC, Markl M, Dall'Armellina E, Han Y, Kozerke S, Kuehne T, Nielles-Vallespin S, Messroghli D, Patel A, Schaeffter T, Simonetti O, Valente AM, Weinsaft JW, Wright G, Zimmerman S, Schulz-Menger J. The growth and evolution of cardiovascular magnetic reso — View Citation

Mathew T, Williams L, Navaratnam G, Rana B, Wheeler R, Collins K, Harkness A, Jones R, Knight D, O'Gallagher K, Oxborough D, Ring L, Sandoval J, Stout M, Sharma V, Steeds RP; British Society of Echocardiography Education Committee. Diagnosis and assessmen — View Citation

Pinto YM, Elliott PM, Arbustini E, Adler Y, Anastasakis A, Böhm M, Duboc D, Gimeno J, de Groote P, Imazio M, Heymans S, Klingel K, Komajda M, Limongelli G, Linhart A, Mogensen J, Moon J, Pieper PG, Seferovic PM, Schueler S, Zamorano JL, Caforio AL, Charro — View Citation

Sharma E, Arunachalam K, Di M, Chu A, Maan A. PVCs, PVC-Induced Cardiomyopathy, and the Role of Catheter Ablation. Crit Pathw Cardiol. 2017 Jun;16(2):76-80. doi: 10.1097/HPC.0000000000000106. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Twenty-four hours Holter monitoring after Magnetic Resonance Imaging	24 Holter monitoring to detect PVCs burden which is defined as =10% of total beats	One year