Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry

Myocarditis Clinical Trial

— MAVERIC  

Official title:

Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05158751
• Other study ID #: KCHRF-MAVERIC REG-0009
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: May 2023

Study information

• Verified date: November 2021
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess potential link between unrecognized myocardial inflammation (myocarditis) and premature ventricular contractions (PVCs) associated with and without reduced Left ventricular ejection fraction (LVEF) through comprehensive diagnostic work up.

Description:

Hypothesized that occult inflammation is clinically under-recognized in patients with symptomatic PVCs with and without Left ventricular (LV) dysfunction and can be a potential link between the 2 conditions. Aimed to evaluate the incidence of underlying inflammation using the Positron emission tomography (PET) scan in patients presenting with symptomatic PVCs enrolled retrospectively in the MAVERIC registry.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients > 18 years of age with mono-morphic or polymorphic PVC burden of =5000 in 24 hours.

• Non-sustained VT was defined as =3 more consecutive beats lasting <30 seconds

Exclusion Criteria:

• History of myocardial infarction,

• Significant flow-limiting coronary artery disease (=50% stenosis) on invasive coronary angiography or CT angiography,

• History of revascularization,

• Significant symptomatic atrial arrhythmias associated with LV dysfunction,

• Severe valvular disease,

• Cardiomyopathy attributed to toxins such as alcohol and illicit drugs,

• History of cardiac arrest,

• History of channelopathies or inherited arrhythmias.

Related Conditions & MeSH terms

• Myocarditis
• Premature Birth
• Premature Ventricular Contractions
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Premature Complexes
• Ventricular Tachycardia (VT)

Locations

Country	Name	City	State
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation	Kansas City Heart Rhythm Institute

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate whether IST + catheter ablation results in optimal clinical response	To evaluate whether IST + catheter ablation results in optimal clinical response in virus negative and FDG-PET positive patients with PVCs with or without reduced LVEF	Retrospective Collection between dates January 2014-January 2023
Primary	Identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF	To identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF through laboratory testing, FDG-PET(18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose - positron emission tomography) scan, Cardiac Magnetic Resonance imaging and/or Endomyocardial biopsy.	Retrospective Collection between dates January 2014-January 2023
Secondary	Ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes	To ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes in virus negative and FDG-PET positive patients with non-ischemic cardiomyopathy, myocardial inflammation and PVCs.	Retrospective Collection between dates January 2014-January 2023