Actively Recruiting

Age: 18Years +
All Genders
ID06730464

Image-Based Prediction of Ventricular Tachycardia Events in Non-ischemic Cardiomyopathy An International Multicenter Study - The IMPROVE-NICM Study

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

500

Participants Needed

4

Research Sites

16 weeks

Total Duration

On this page

Sponsors

C

Centro Medico Teknon

Lead Sponsor

H

Humanitas Research Hospital IRCCS, Rozzano-Milan

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how to better predict the risk of sudden cardiac death (SCD) and dangerous heart rhythms in patients with non-ischemic cardiomyopathy (NICM), a heart condition affecting the left ventricle. Current methods based on low heart function do not adequately identify all patients at risk, as many with better heart function still suffer from sudden cardiac arrests. This study focuses on detailed heart tissue imaging (using late gadolinium enhancement cardiac magnetic resonance, LGE-CMR) to identify scar and border zone masses that might better predict these risks. The study uses advanced image processing software (ADAS 3D LV) to analyze scar tissue characteristics such as border zone mass and heterogeneous tissue channels (HTC) in the heart. It includes a main retrospective cohort study, a prospective validation cohort, and a retrospective subgroup analysis assessing changes in scar features over time. Participants are patients diagnosed with NICM without previous arrhythmia events, who have had or will have LGE-CMR scans as part of their clinical care. Participants will be followed for up to 100 months from their first CMR scan to see if they experience sudden cardiac death, sustained ventricular arrhythmias, or receive defibrillator therapy. Researchers will collect data on heart function, scar characteristics, patient age, and genetic information when available. No treatments are assigned by the study; it observes outcomes based on existing clinical data and imaging. The study aims to improve risk classification for these patients over a period of at least two years or more.

CONDITIONS

Brief Title

Image-Based Prediction of Ventricular Tachycardia Events in Non-ischemic Cardiomyopathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of non-ischemic heart disease involving the left ventricle, including dilated cardiomyopathy, non-dilated left ventricular cardiomyopathy, or post-myocarditis cardiomyopathy
  • Life expectancy of more than 1 year with good functional status
  • Signed informed consent
  • At least one late gadolinium enhancement cardiac MRI (LGE-CMR) already performed
  • No ventricular arrhythmia events at the time of first LGE-CMR study
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Life expectancy less than 1 year or poor functional status (NYHA IV class)
  • Other structural heart diseases such as ischemic, congenital, or arrhythmogenic right ventricular cardiomyopathy
  • No LGE-CMR at enrollment or unavailable LGE-CMR data
  • Previously documented sustained ventricular arrhythmias at time of first LGE-CMR
  • Receiving other investigational treatments
  • Medical, geographical, or social factors preventing participation or inability to give informed consent
  • Patient refusal to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 - At enrollment

Participants undergo cardiac MRI imaging to assess heart scar characteristics as part of standard clinical care.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 100 months

Participants are observed over time to monitor for sudden cardiac death, sustained ventricular arrhythmia, or defibrillator therapy.

Follow-up visits as per clinical practice

Trial Site Locations

Total: 4 locations

1

Humanitas Research Hospital (Rozzano - Milan, Italy)

Milan, Italy, Italy, 20089

Actively Recruiting

2

Hospital de la Luz

Lispon, Portugal, Portugal, 1500-650

Actively Recruiting

3

Teknon Medical Center

Barcelona, Barcelona, Spain, 08022

Actively Recruiting

4

Virgen del Rocio University Hospital

Seville, Sevilla, Spain, 41013

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

1

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Published Research Related To This Trial

Left ventricular midwall fibrosis as a predictor of mortality and morbidity after cardiac resynchronization therapy in patients with nonischemic cardiomyopathy.

Francisco Leyva, Robin J Taylor, Paul W X Foley...

https://pubmed.ncbi.nlm.nih.gov/23021326

Association of fibrosis with mortality and sudden cardiac death in patients with nonischemic dilated cardiomyopathy.

Ankur Gulati, Andrew Jabbour, Tevfik F Ismail...

https://pubmed.ncbi.nlm.nih.gov/23462786

Improved Risk Stratification for Ventricular Arrhythmias and Sudden Death in Patients With Nonischemic Dilated Cardiomyopathy.

Andrea Di Marco, Pamela Frances Brown, Joshua Bradley...

https://pubmed.ncbi.nlm.nih.gov/34112317

Risk Stratification in Nonischemic Dilated Cardiomyopathy Using CMR Imaging: A Systematic Review and Meta-Analysis.

Christian Eichhorn, David Koeckerling, Rohin K Reddy...

https://pubmed.ncbi.nlm.nih.gov/39298146

Late Gadolinium Enhancement and the Risk for Ventricular Arrhythmias or Sudden Death in Dilated Cardiomyopathy: Systematic Review and Meta-Analysis.

Andrea Di Marco, Ignasi Anguera, Matthias Schmitt...

https://pubmed.ncbi.nlm.nih.gov/28017348

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

Use of cardiovascular magnetic resonance for risk stratification in chronic heart failure: prognostic value of late gadolinium enhancement in patients with non-ischaemic dilated cardiomyopathy.

Stephanie Lehrke, Dirk Lossnitzer, Michael Schöb...

https://pubmed.ncbi.nlm.nih.gov/21097819

Personalizing Risk Stratification for Sudden Death in Dilated Cardiomyopathy: The Past, Present, and Future.

Brian P Halliday, John G F Cleland, Jeffrey J Goldberger...

https://pubmed.ncbi.nlm.nih.gov/28696268

Catheter Ablation of Ventricular Tachycardia in Structural Heart Disease: Indications, Strategies, and Outcomes-Part II.

Srinivas R Dukkipati, Jacob S Koruth, Subbarao Choudry...

https://pubmed.ncbi.nlm.nih.gov/29216988