The Prognostic Significance of Fibrosis Detection in Cardiomyopathy - Full Text View

Sponsor:	Royal Brompton & Harefield NHS Foundation Trust
Information provided by:	Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT00930735

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:

MedlinePlus related topics: Cardiomyopathy Coronary Artery Disease Heart Failure

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):

Dweck MR, Joshi S, Murigu T, Alpendurada F, Jabbour A, Melina G, Banya W, Gulati A, Roussin I, Raza S, Prasad NA, Wage R, Quarto C, Angeloni E, Refice S, Sheppard M, Cook SA, Kilner PJ, Pennell DJ, Newby DE, Mohiaddin RH, Pepper J, Prasad SK. Midwall fibrosis is an independent predictor of mortality in patients with aortic stenosis. J Am Coll Cardiol. 2011 Sep 13;58(12):1271-9.

O'Hanlon R, Grasso A, Roughton M, Moon JC, Clark S, Wage R, Webb J, Kulkarni M, Dawson D, Sulaibeekh L, Chandrasekaran B, Bucciarelli-Ducci C, Pasquale F, Cowie MR, McKenna WJ, Sheppard MN, Elliott PM, Pennell DJ, Prasad SK. Prognostic significance of myocardial fibrosis in hypertrophic cardiomyopathy. J Am Coll Cardiol. 2010 Sep 7;56(11):867-74. Epub 2010 Jun 25.

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 May 24, 2012