Actively Recruiting

Age: 18Years +
All Genders
ID06730607

Image-Based Prediction of Ventricular Tachycardia Events in Post-Myocarditis Patients: an International Multicenter Case-control Study

Led by Centro Medico Teknon · Updated on 2024-12-12

150

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Ventricular arrhythmias are often linked to structural heart diseases such as myocardial infarction, myocarditis, and non-ischemic cardiomyopathies. This research explores the role of scar tissue in the heart, particularly in patients who have had myocarditis, using advanced cardiac magnetic resonance imaging to analyze scar patterns and predict arrhythmia risk. The study aims to improve risk assessment beyond the current standard based on left ventricular ejection fraction, focusing on patients without previous arrhythmia signs. The study is observational and compares patients who experience sudden cardiac death or sustained ventricular arrhythmias to those who do not, analyzing heart scar characteristics through imaging data. Researchers will evaluate scar mass, border zone channels, and other tissue features obtained from cardiac MRI performed at least six months after myocarditis diagnosis. The goal is to better predict arrhythmia risk and refine implantable cardioverter-defibrillator (ICD) therapy recommendations. Participants will undergo cardiac magnetic resonance imaging and clinical follow-up for up to two years to monitor for arrhythmic events or sudden cardiac death. Researchers will collect data on heart function and scar tissue features, including advanced imaging markers. Outcomes include the incidence of sudden cardiac death, sustained ventricular tachycardia, and appropriate ICD therapies. Safety, consent, and feasibility will be ensured throughout the study period ending in December 2026.

CONDITIONS

Brief Title

Image-Based Prediction of Ventricular Tachycardias in Post-Myocarditis Patients: an International Multicenter Case-control Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Diagnosis of myocarditis more than 6 months before joining the study
  • Signed informed consent
  • Cardiac magnetic resonance imaging performed more than 6 months after myocarditis diagnosis
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Pregnancy
  • Other structural heart diseases such as congenital or non-ischemic conditions
  • Active myocarditis
  • Myocarditis diagnosis less than 6 months ago
  • Previously documented sustained ventricular arrhythmias
  • Unable or contraindicated to undergo late gadolinium enhancement cardiac magnetic resonance imaging
  • Receiving other investigational treatments
  • Medical, geographical, or social factors making participation impractical
  • Inability to provide written informed consent or refusal to participate

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Occurs once after screening

Participants undergo cardiac magnetic resonance imaging (CMR) and other diagnostic tests to assess scar mass, BZC mass, and other cardiac features related to myocarditis.

1 imaging visit

Long-term Monitoring

Duration - Up to 2 years

Participants are observed for up to 2 years to record the occurrence of sudden cardiac death, sustained ventricular arrhythmias, or defibrillator therapy.

Follow-up visits as needed for monitoring

Trial Site Locations

Total: 3 locations

1

Humanitas Research Hospital

Rozzano, Milan, Italy, 20089

Actively Recruiting

2

Azienda Ospedaliero-Universitaria Pisana

Pisa, Pisa, Italy, 56126

Actively Recruiting

3

Teknon Medical Center

Barcelona, Barcelona, Spain, 08022

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Scar Characterization to Predict Life-Threatening Arrhythmic Events and Sudden Cardiac Death in Patients With Cardiac Resynchronization Therapy: The GAUDI-CRT Study.

Juan Acosta, Juan Fernández-Armenta, Roger Borràs...

https://pubmed.ncbi.nlm.nih.gov/28780194

Cardiovascular magnetic resonance determinants of ventricular arrhythmic events after myocardial infarction.

Beatriz Jáuregui, David Soto-Iglesias, Diego Penela...

https://pubmed.ncbi.nlm.nih.gov/34849726

Late gadolinium enhancement and the risk of ventricular arrhythmias and sudden death in NYHA class I patients with non-ischaemic cardiomyopathy.

Andrea Di Marco, Pamela Brown, Gemma Mateus...

https://pubmed.ncbi.nlm.nih.gov/36781200