- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02326324
The UHSM Cardiovascular Magnetic Resonance Study (UHSM CMR)
The University Hospital of South Manchester Cardiovascular Magnetic Resonance Study
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M23 9LT
- University Hospital of South Manchester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Collaborators
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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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