Clinical trial NCT02326324: The UHSM Cardiovascular Magnetic Resonance Study
Official title: The University Hospital of South Manchester Cardiovascular Magnetic Resonance Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Pittsburgh Medical Center
First posted: 2014-12-29
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing clinically indicated CMR scanning (i.e. patients with suspected or confirmed cardiovascular disease)

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.

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.

Primary outcomes:
measure: All cause mortality
timeFrame: 10 years with planned interim analyses
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 10 years with planned interim analyses
measure: Hospitalisation for heart failure
timeFrame: 10 years with planned interim analyses
measure: Development of cardiovascular disease
timeFrame: 10 years with planned interim analyses
measure: Development of complications of cardiovascular disease
timeFrame: 10 years with planned interim analyses
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
state: Greater Manchester
Study officials:
affiliation: University Hospital of South Manchester
name: Christopher A Miller, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of South Manchester
name: Matthias Schmitt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Di Marco A, Brown PF, Bradley J, Nucifora G, Anguera I, Miller CA, Schmitt M. Extracellular volume fraction improves risk-stratification for ventricular arrhythmias and sudden death in non-ischaemic cardiomyopathy. Eur Heart J Cardiovasc Imaging. 2023 Mar 21;24(4):512-521. doi: 10.1093/ehjci/jeac142.