NCT02326324

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2015Dec 2029

First Submitted

Initial submission to the registry

December 22, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

January 5, 2015

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

14.9 years

First QC Date

December 22, 2014

Last Update Submit

September 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    10 years with planned interim analyses

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of South Manchester

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

Related Publications (2)

  • Bradley J, Schelbert EB, Bonnett LJ, Lewis GA, Lagan J, Orsborne C, Brown PF, Black N, Naish JH, Williams SG, McDonagh T, Schmitt M, Miller CA. Growth differentiation factor-15 in patients with or at risk of heart failure but before first hospitalisation. Heart. 2024 Jan 10;110(3):195-201. doi: 10.1136/heartjnl-2023-322857.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood sampling will be performed on the same day as CMR scanning

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Christopher A Miller, MBChB, PhD

    University Hospital of South Manchester

    PRINCIPAL INVESTIGATOR
  • Matthias Schmitt, MD, PhD

    University Hospital of South Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

December 29, 2014

Study Start

January 5, 2015

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations