Concealed Myocardial Abnormalities by Cardiac Magnetic Resonance Imaging in Idiopathic VT

NCT06146556 | Active Not Recruiting DMC

• 1 other identifier: Idiopathic VT imaging
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic Ventricular arrhythmia (VAs) refers to VAs that occur in the absence of clinically apparent structural heart disease. The outflow tracts (OTs) are the most common origin of idiopathic VAs and PVCs, accounting for approximately 10% of all patients referred for evaluation of VAs with the RVOT being the origin of about 70-80% of these arrhythmias. Studies have shown that increased PVC burden was associated with reduced LV function, a higher incidence of heart failure, and a higher risk of death. The diagnosis, prognostication and treatment of patients with VAs are challenging. A routine diagnostic workup that includes transthoracic echocardiography and an assessment for the presence of coronary artery disease (CAD) as recommended by current clinical guidelines cannot recognize focal structural abnormalities or underlying structural heart disease (SHD) in a substantial proportion of patients. Cardiac magnetic resonance (CMR) provides an excellent assessment of cardiac morphology and function and enables a detailed myocardial tissue characterization with a high degree of precision. CMR is widely regarded as the gold standard for identifying structural arrhythmogenic substrates in patients with VAs and normal echocardiography.

Conditions

Premature Ventricular Contractions

Keywords

idiopathic VAs

Outcome Measures

Primary Outcomes (1)

• Assess the diagnostic yield of cardiac MRI in early detection of biventricular dysfunction in patients with idiopathic VAs

  the value of CMR in evaluation of ventricular dysfunction in patients with ventricular arrhythmias

  one year

Secondary Outcomes (3)

• Assess the clinical predictors of myocardial dysfunction

  one year

• Assess the PVCs burden association with myocardial abnormalities

  one year

• Assess the PVCs morphology association with myocardial abnormalities

  one year

Interventions

catheter based ablation PROCEDURE

electrophysiological catheter based ablation of ventricular arrhythmia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presented with idiopathic ventricular arrhythmias with normal diagnostic routine workup at Assiut university heart hospital.

You may qualify if:

• All patients presented with idiopathic ventricular arrhythmias with normal diagnostic routine workup at Assiut university heart hospital. Diagnostic work up including a normal ECG with no changes suggestive of structural heart disease, normal echocardiography findings and no evidence of CAD on either invasive or non-invasive imaging

You may not qualify if:

• (1) known history of cardiac disease (CAD, cardiomyopathy, congenital heart disease, more than mild valvular disease, previous cardiac surgery of any type), any severe systemic disease with cardiac involvement.
• (2) Allergy to gadolinium-based contrast agents, an estimated glomerular filtration rate \< 30 mL/min/1.73 m2.
• (3) Any contraindication to the MR environment (e.g., MR-unsafe implants/devices, shrapnel injury), pregnancy and claustrophobia

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (1)

• 1.Aliot EM, Stevenson WG, Almendral-Garrote JM, Bogun F, Calkins CH, Delacretaz E, et al. EHRA/HRS expert consensus on catheter ablation of ventricular arrhythmias. Vol. 11, Europace. 2009. p. 771-817 2.Kim YH, Chen SA, Ernst S, Guzman CE, Han S, Kalarus Z, et al. 2019 APHRS expert consensus statement on three-dimensional mapping systems for tachycardia developed in collaboration with HRS, EHRA, and LAHRS. Vol. 36, Journal of Arrhythmia. Wiley-Blackwell; 2020. p. 215-70. 3..Pedersen CT, Kay GN, Kalman J, Borggrefe M, Della-Bella P, Dickfeld T, et al. EHRA/HRS/APHRS expert consensus on ventricular arrhythmias. EP Europace 2014 Sep 1. Available from: https://dx.doi.org/10.1093/europace/euu194 4.Andreini D, Dello Russo A, Pontone G, Mushtaq S, Conte E, Perchinunno M, et al. CMR for Identifying the Substrate of Ventricular Arrhythmia in Patients With Normal Echocardiography. Cardiovascular Imaging . 2020 Feb 1 https://www.jacc.org/doi/10.1016/j.jcmg.2019.04.023 5.Muser D, Santangeli P, Castro SA, Casado Arroyo R, Maeda S, Benhayon DA, et al. Risk Stratification of Patients With Apparently Idiopathic Premature Ventricular Contractions: A Multicenter International CMR Registry. JACC Clin Electrophysiol. 2020 Jun 1;6(6):722-35

  BACKGROUND

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• shimaa sayed, MD

  Lecturer of cardiovascular medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: November 24, 2023
• Study Start: January 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

EG (1)