MedTrace Logo

CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy: an International Registry (DERIVATE)

NCT03352648 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2019-06-06

No results posted yet for this study

Summary

The DERIVATE study was conceived to integrate the information resulted from clinical data, transthoracic echocardiography, and cardiac magnetic resonance (CMR) imaging to provide a more reliable risk stratification in patients affected by heart failure (HF) and worthy of prophylactic implanted cardioverter defibrillator (ICD) therapy. The main purposes of this multicenter registry are to: 1) determine CMR findings, and specifically late gadolinium enhancement (LGE) features, T1 mapping, and extracellular volume (ECV) that predict sudden cardiac death (SCD) and ventricular arrhythmia; 2) provide a comprehensive clinical and imaging score that effectively improves the selection of patients who deserve a prophylactic ICD therapy; 3) evaluate the contribution of machine learning to predict major adverse cardiac events (MACE) as compared to standard clinical scores.

Conditions

Sponsors & Collaborators

  • University of Lausanne Hospitals

    collaborator OTHER

  • Gianluca Pontone, MD, PhD

    lead OTHER

Principal Investigators

  • Gianluca Pontone, MD · IRCCS Centro Cardiologico Monzino, Milano, Italy

  • Andrea Igoren Guaricci, MD · University Hospital Policlinico Consorziale of Bari, Bari , Italy

  • Jurg Schwitter, MD · Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland

  • Pier Giorgio Masci, MD · Lausanne University Hospital-CHUV, Lausanne, Vaud, Switzerland

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2019-08-31
Completion
2020-12-31

Countries

  • United States
  • Belgium
  • Greece
  • Italy
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03352648 on ClinicalTrials.gov