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Clinical Trials/NCT02326324
NCT02326324
Active, not recruiting
Not Applicable

The University Hospital of South Manchester Cardiovascular Magnetic Resonance Study

Manchester University NHS Foundation Trust1 site in 1 country10,000 target enrollmentJanuary 5, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Manchester University NHS Foundation Trust
Enrollment
10000
Locations
1
Primary Endpoint
All cause mortality
Status
Active, not recruiting
Last Updated
7 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2015
End Date
December 1, 2029
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

All cause mortality

Time Frame: 10 years with planned interim analyses

Secondary Outcomes

  • Cardiovascular death(10 years with planned interim analyses)
  • Hospitalisation for heart failure(10 years with planned interim analyses)
  • Development of cardiovascular disease(10 years with planned interim analyses)
  • Development of complications of cardiovascular disease(10 years with planned interim analyses)

Study Sites (1)

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