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The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00930735
First received: June 27, 2009
Last updated: June 29, 2009
Last verified: April 2009
History of Changes
  Purpose

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


Condition
Cardiomyopathy
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prognostic Significance of Fibrosis Detection in Ischemic and Non-Ischemic Cardiomyopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Ventricular arrhythmias [ Time Frame: 3 ] [ Designated as safety issue: No ]
  • Unplanned heart failure admissions [ Time Frame: 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ejection fraction [ Time Frame: 3 ] [ Designated as safety issue: No ]
  • NYHA status [ Time Frame: 3 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum and plasma and myocardium


Estimated Enrollment: 3000
Study Start Date: January 2000
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Myocardial fibrosis, outcomes
Groups with none and variable amounts of myocardial fibrosis

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • presence of an ischaemic or non-ischaemic cardiomyopathic process
  • no contraindication to contrast enhanced C MR
  • GFR >30

Exclusion Criteria:

  • ESRF
  • Contraindication to CM R
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930735

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Sanjay K Prasad, MD Royal Brompton and Harefield Foundation Trust
  More Information

No publications provided by Royal Brompton & Harefield NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanjay K Prasad, Royal Brompton Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT00930735     History of Changes
Other Study ID Numbers: 09/0904
Study First Received: June 27, 2009
Last Updated: June 29, 2009
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Fibrosis
Cardiomyopathies
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013