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NCT00930735 Clinical Trial

The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

Coronary Artery Disease Clinical Trial

Official title:
The Prognostic Significance of Fibrosis Detection in Ischemic and Non-ischemic Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00930735
Other study ID # 09/0904
Secondary ID
Status Recruiting
Phase
First received June 27, 2009
Last updated April 19, 2018
Start date January 2000
Est. completion date July 2025

Study information
Verified date April 2018
Source Royal Brompton & Harefield NHS Foundation Trust
Contact Sanjay K Prasad, MD
Phone +442073528121
Email s.prasad@rbht.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The presence of scar within heart muscle can act as a substrate for abnormal rhythm problems and lead to the developement of heart failure

Clinical significance Correlation with biomarkers and genetic markers

Description:

Patients will undergo cardiovascular magnetic resonance (CMR) to include measurement of left ventricular volumes, ejection fraction, detection of inflammation (via STIR sequences) where appropriate, early gadolinium enhancement, late gadolinium enhancement, first pass perfusion using pharmacological stress imaging (contraindications to include comorbidities that do not permit pharmacological stress agents e.g. severe asthma, severe or symptomatic aortic stenosis)

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date July 2025
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- presence of an ischaemic or non-ischaemic cardiomyopathic process

- no contraindication to contrast enhanced CMR

- GFR >30

Exclusion Criteria:

- ESRF

- Contraindication to CM R

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Royal Brompton Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary All cause mortality 3 years
Primary Ventricular arrhythmias 3 years
Primary Unplanned heart failure admissions 3 years
Secondary Ejection fraction 3
Secondary NYHA status 3
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