NCT05078125

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

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 2, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

October 2, 2021

Last Update Submit

January 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

24 hours Holter monitoring

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor of cardiology .Luxor International Hospital

Study Record Dates

First Submitted

October 2, 2021

First Posted

October 14, 2021

Study Start

April 1, 2022

Primary Completion

December 31, 2022

Study Completion

March 30, 2023

Last Updated

January 25, 2022

Record last verified: 2022-01