The UHSM Cardiovascular Magnetic Resonance Study (UHSM CMR)

January 31, 2023 updated by: Manchester University NHS Foundation Trust

The University Hospital of South Manchester Cardiovascular Magnetic Resonance Study

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.

Study Overview

Status

Active, not recruiting

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 Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M23 9LT
        • University Hospital of South Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing clinically indicated CMR scanning (i.e. patients with suspected or confirmed cardiovascular disease)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 10 years with planned interim analyses
10 years with planned interim analyses

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular death
Time Frame: 10 years with planned interim analyses
10 years with planned interim analyses
Hospitalisation for heart failure
Time Frame: 10 years with planned interim analyses
10 years with planned interim analyses
Development of cardiovascular disease
Time Frame: 10 years with planned interim analyses
10 years with planned interim analyses
Development of complications of cardiovascular disease
Time Frame: 10 years with planned interim analyses
10 years with planned interim analyses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 5, 2015

Primary Completion (ANTICIPATED)

December 1, 2029

Study Completion (ANTICIPATED)

December 1, 2029

Study Registration Dates

First Submitted

December 22, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (ESTIMATE)

December 29, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/NW/1165
  • 2014CD013 (OTHER: Manchester University NHS Foundation Trust)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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