UHSM CMR: The UHSM Cardiovascular Magnetic Resonance Study

Sponsor
Manchester University NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT02326324
Collaborator
University of Pittsburgh Medical Center (Other)
10,000
Enrollment
1
Location
178.9
Anticipated Duration (Months)
55.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to investigate the diagnostic and prognostic utility of cardiovascular magnetic resonance (CMR) imaging in a large cohort of unselected patients who are undergoing CMR scanning for clinical indications (i.e. suspected/confirmed cardiovascular disease). CMR indices will be related to the presence and severity of cardiovascular disease and other markers of cardiovascular and health status.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Patients will undergo CMR scanning in the usual clinical manner. As part of the study, patients will undergo approximately 5 minutes of extra CMR scanning. Cardiovascular anatomical, structural and functional data will be recorded, including data pertaining to myocardial characteristics (e.g. extracellular volume, oedema, fibrosis, infarction, function, perfusion), pericardial disease; valvular disease; vascular structure and function.

    Blood sampling will be performed on the same day as CMR scanning for assessment of serum/plasma markers of cardiovascular disease and health status, and DNA analysis. Health questionnaires will be completed on the day of CMR scanning.

    Follow-up information regarding health status, demographics and concurrent medical conditions and treatments will be obtained over a 10 year period following CMR scanning.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The University Hospital of South Manchester Cardiovascular Magnetic Resonance Study
    Actual Study Start Date :
    Jan 5, 2015
    Anticipated Primary Completion Date :
    Dec 1, 2029
    Anticipated Study Completion Date :
    Dec 1, 2029

    Outcome Measures

    Primary Outcome Measures

    1. All cause mortality [10 years with planned interim analyses]

    Secondary Outcome Measures

    1. Cardiovascular death [10 years with planned interim analyses]

    2. Hospitalisation for heart failure [10 years with planned interim analyses]

    3. Development of cardiovascular disease [10 years with planned interim analyses]

    4. Development of complications of cardiovascular disease [10 years with planned interim analyses]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Any adult patient undergoing clinically indicated CMR scanning at the UHSM CMR Unit.

    Exclusion Criteria:

    Age < 18 years, imprisonment, inability to provide informed consent.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University Hospital of South ManchesterManchesterGreater ManchesterUnited KingdomM23 9LT

    Sponsors and Collaborators

    • Manchester University NHS Foundation Trust
    • University of Pittsburgh Medical Center

    Investigators

    • Principal Investigator: Christopher A Miller, MBChB, PhD, University Hospital of South Manchester
    • Principal Investigator: Matthias Schmitt, MD, PhD, University Hospital of South Manchester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manchester University NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT02326324
    Other Study ID Numbers:
    • 14/NW/1165
    • 2014CD013
    First Posted:
    Dec 29, 2014
    Last Update Posted:
    Sep 21, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2021