The UHSM Cardiovascular Magnetic Resonance Study

Active, not recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT02326324
• Lead Sponsor: Manchester University NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-29
• Study Start: 2015-01-05
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	10 years with planned interim analyses

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital of South Manchester; 🇬🇧 Manchester, Greater Manchester, United Kingdom