Clinical trial NCT05078125: Electrocardiographic and Cardiac Magnetic Resonance Predictors of Ventricular Arrhythmias in Cardiomyopathic Patients
Official title: ECG and CMR for Predicting PVCs in Cardiomyopathic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Ventricular Complex
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is anticipated to include all consecutive eligible cardiomyopathic patients.

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

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

Eligibility criteria: 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 .

Primary outcomes:
measure: Twenty-four hours Holter monitoring after Magnetic Resonance Imaging
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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 assessment of dilated cardiomyopathy: a guideline protocol from the British Society of Echocardiography. Echo Res Pract. 2017 Jun;4(2):G1-G13. doi: 10.1530/ERP-16-0037.
citation: Pinto YM, Elliott PM, Arbustini E, Adler Y, Anastasakis A, Bohm 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, Charron P. Proposal for a revised definition of dilated cardiomyopathy, hypokinetic non-dilated cardiomyopathy, and its implications for clinical practice: a position statement of the ESC working group on myocardial and pericardial diseases. Eur Heart J. 2016 Jun 14;37(23):1850-8. doi: 10.1093/eurheartj/ehv727. Epub 2016 Jan 19.
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.
citation: 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 resonance: a 20-year history of the Society for Cardiovascular Magnetic Resonance (SCMR) annual scientific sessions. J Cardiovasc Magn Reson. 2018 Jan 31;20(1):8. doi: 10.1186/s12968-018-0429-z.