Clinical trial NCT05158751: Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry
Official title: Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myocarditis
Premature Ventricular Contractions
Ventricular Tachycardia (VT)
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
Collaborators: name: Kansas City Heart Rhythm Institute
First posted: 2021-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females with PVC and ventricular tachycardia (VT) will be enrolled if they meet the inclusion/exclusion criteria

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF
timeFrame: Retrospective Collection between dates January 2014-January 2023
Secondary outcomes:
measure: Ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes
timeFrame: Retrospective Collection between dates January 2014-January 2023
Other outcomes:
measure: Evaluate whether IST + catheter ablation results in optimal clinical response
timeFrame: Retrospective Collection between dates January 2014-January 2023
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
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