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T1-CMR: International T1 Multicentre CMR Outcome Study

Sponsor
King's College London (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02407197
Collaborator
(none)
1,629
Enrollment
4
Locations
143
Anticipated Duration (Months)
407.3
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Myocardial fibrosis is the fundamental substrate for the development of heart failure.

Cardiovascular magnetic resonance (CMR) allows non-invasive assessment of myocardial fibrosis based on late gadolinium enhancement (LGE) and T1 mapping.

Patients: Prospective longitudinal observational multicenter study of consecutive patients with suspected or known non-ischemic cardiomyopathy.

Imaging: Non-invasive measures of myocardial fibrosis: native T1, extracellular volume fraction (ECV) and LGE.

Primary endpoints: all cause and cardiovascular mortality.

Secondary endpoints: arrhythmic composite and HF composite endpoints.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1629 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    International T1 Multicentre CMR Study
    Actual Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2017
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Survival [1 year]

      number of deaths

    Secondary Outcome Measures

    1. Rate of Arrhythmia [1 year]

      number of fatal or aborted sudden cardiac death events (including a documented appropriate shock from ICD)

    2. Rate of HF events [1 year]

      Number of HF death and unplanned HF hospitalization

    3. Rate of deaths due to cardiovascular causes [1 year]

      Number of composite of sudden cardiac death (SCD), death from HF, death from stroke or thromboembolic event

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. adults > 18 years of age

    2. clinical indication for CMR

    3. able to provide informed consent

    Exclusion criteria:

    contraindications for cardiac magnetic resonance imaging due to MR unsafe devices or objects

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vincent's University Sydney New South Wales Australia NSW 2010
    2 German Heart Institute Berlin Berlin Germany 13353
    3 Guy's and St. Thomas' Hospital Trust London United Kingdom SE1 7EH
    4 King's College Hospital London United Kingdom SE5 9RS

    Sponsors and Collaborators

    • King's College London

    Investigators

    • Principal Investigator: Eike Nagel, MD, PhD, King's College London

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eike Nagel, Global Chief Investigator, King's College London
    ClinicalTrials.gov Identifier:
    NCT02407197
    Other Study ID Numbers:
    • 2011-T1-MC
    First Posted:
    Apr 2, 2015
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eike Nagel, Global Chief Investigator, King's College London
    T1 mapping
    CMR
    Outcome
    multicenter
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Coronary Artery Disease
    Cardiomyopathies
    Inflammation

    Study Results

    No Results Posted as of Jun 24, 2022