Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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 years ] [ Designated as safety issue: No ]
  • Unplanned heart failure admissions [ Time Frame: 3 years ] [ 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: July 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Myocardial fibrosis, outcomes
Groups with none and variable amounts of myocardial fibrosis

Detailed 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)

  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 CMR 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 CMR
  • GFR >30

Exclusion Criteria:

  • ESRF
  • Contraindication to CM R
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Prasad, Consultant Cardiologist, Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00930735     History of Changes
Other Study ID Numbers: 09/0904
Study First Received: June 27, 2009
Last Updated: February 5, 2015
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on February 25, 2015