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The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

Sponsor
Royal Brompton & Harefield NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT00930735
Collaborator
(none)
3,000
Enrollment
1
Location
306
Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The presence of scar within heart muscle can act as a substrate for abnormal rhythm problems and lead to the developement of heart failure

Clinical significance Correlation with biomarkers and genetic markers

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients will undergo cardiovascular magnetic resonance (CMR) to include measurement of left ventricular volumes, ejection fraction, detection of inflammation (via STIR sequences) where appropriate, early gadolinium enhancement, late gadolinium enhancement, first pass perfusion using pharmacological stress imaging (contraindications to include comorbidities that do not permit pharmacological stress agents e.g. severe asthma, severe or symptomatic aortic stenosis)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Prognostic Significance of Fibrosis Detection in Ischemic and Non-ischemic Cardiomyopathy
    Study Start Date :
    Jan 1, 2000
    Anticipated Primary Completion Date :
    Apr 30, 2020
    Anticipated Study Completion Date :
    Jul 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Myocardial fibrosis, outcomes

    Groups with none and variable amounts of myocardial fibrosis

    Outcome Measures

    Primary Outcome Measures

    1. All cause mortality [3 years]

    2. Ventricular arrhythmias [3 years]

    3. Unplanned heart failure admissions [3 years]

    Secondary Outcome Measures

    1. Ejection fraction [3]

    2. NYHA status [3]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • presence of an ischaemic or non-ischaemic cardiomyopathic process

    • no contraindication to contrast enhanced CMR

    • GFR >30

    Exclusion Criteria:

    • ESRF

    • Contraindication to CM R

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Brompton Hospital London United Kingdom SW3 6NP

    Sponsors and Collaborators

    • Royal Brompton & Harefield NHS Foundation Trust

    Investigators

    • Principal Investigator: Sanjay K Prasad, MD, Royal Brompton and Harefield Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanjay Prasad, Consultant Cardiologist, Royal Brompton & Harefield NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT00930735
    Other Study ID Numbers:
    • 09/0904
    First Posted:
    Jun 30, 2009
    Last Update Posted:
    Apr 23, 2018
    Last Verified:
    Apr 1, 2018
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Cardiomyopathies

    Study Results

    No Results Posted as of Apr 23, 2018