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Not yet recruiting NCT05158751

Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry

— Observational Myocarditis Premature Ventricular Contractions Ventricular Tachycardia (VT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Myocarditis, Premature Ventricular Contractions, Ventricular Tachycardia (VT). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF [Time frame: Retrospective Collection between dates January 2014-January 2023]
Secondary outcome measures (1)
  • Ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes [Time frame: Retrospective Collection between dates January 2014-January 2023]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Kansas City Heart Rhythm Institute — Overland Park

Publications

  • Ahn MS. Current Concepts of Premature Ventricular Contractions. J Lifestyle Med. 2013 Mar;3(1):26-33. Epub 2013 Mar 31. PMID 26064834
  • Ng GA. Treating patients with ventricular ectopic beats. Heart. 2006 Nov;92(11):1707-12. doi: 10.1136/hrt.2005.067843. No abstract available. PMID 17041126
  • Kennedy HL, Whitlock JA, Sprague MK, Kennedy LJ, Buckingham TA, Goldberg RJ. Long-term follow-up of asymptomatic healthy subjects with frequent and complex ventricular ectopy. N Engl J Med. 1985 Jan 24;312(4):193-7. doi: 10.1056/NEJM198501243120401. PMID 2578212
  • Lakkireddy D, Turagam MK, Yarlagadda B, Dar T, Hamblin M, Krause M, Parikh V, Bommana S, Atkins D, Di Biase L, Mohanty S, Rosamond T, Carroll H, Nydegger C, Wetzel L, Gopinathannair R, Natale A. Myocarditis Causing Premature Ventricular Contractions: Insights From the MAVERIC Registry. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007520. doi: 10.1161/CIRCEP.119.007520. Epub 2019 Dec 16. PMID 31838913
  • Ruberman W, Weinblatt E, Goldberg JD, Frank CW, Shapiro S. Ventricular premature beats and mortality after myocardial infarction. N Engl J Med. 1977 Oct 6;297(14):750-7. doi: 10.1056/NEJM197710062971404. PMID 70750
  • Whiting RB. Ventricular premature contractions. Which should be treated? Arch Intern Med. 1980 Nov;140(11):1423-6. PMID 6159832
  • Piccolo E, Raviele A. [Clinical and prognostic significance of hyperkinetic ventricular arrhythmias]. G Ital Cardiol. 1983;13(4):276-89. Italian. PMID 6350092
  • Kastor JA. Ventricular premature beats. Adv Intern Med. 1983;28:63-91. PMID 6340432

Identifiers

NCT: NCT05158751 · KCHRF-MAVERIC REG-0009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗