The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanjay Prasad, Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00930735
First received: June 27, 2009
Last updated: February 5, 2015
Last verified: February 2015

June 27, 2009
February 5, 2015
January 2000
April 2015   (final data collection date for primary outcome measure)
  • All cause mortality [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Ventricular arrhythmias [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Unplanned heart failure admissions [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00930735 on ClinicalTrials.gov Archive Site
  • Ejection fraction [ Time Frame: 3 ] [ Designated as safety issue: No ]
  • NYHA status [ Time Frame: 3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Prognostic Significance of Fibrosis Detection in Cardiomyopathy
The Prognostic Significance of Fibrosis Detection in Ischemic and Non-ischemic Cardiomyopathy

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

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)

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum and plasma and myocardium

Probability Sample

Consecutive referrals for CMR from tertiary and nontertiary referral hospitals scanned to evaluate presence and amount of myocardial scarring.

  • Cardiomyopathy
  • Coronary Artery Disease
Not Provided
Myocardial fibrosis, outcomes
Groups with none and variable amounts of myocardial fibrosis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
July 2016
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00930735
09/0904
No
Sanjay Prasad, Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
Not Provided
Principal Investigator: Sanjay K Prasad, MD Royal Brompton and Harefield Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP