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The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT00930735
Recruitment Status : Recruiting
First Posted : June 30, 2009
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Sanjay Prasad, Royal Brompton & Harefield NHS Foundation Trust

Brief 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


Condition or disease
Cardiomyopathy Coronary Artery Disease

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)

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prognostic Significance of Fibrosis Detection in Ischemic and Non-ischemic Cardiomyopathy
Study Start Date : January 2000
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Group/Cohort
Myocardial fibrosis, outcomes
Groups with none and variable amounts of myocardial fibrosis



Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 3 years ]
  2. Ventricular arrhythmias [ Time Frame: 3 years ]
  3. Unplanned heart failure admissions [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Ejection fraction [ Time Frame: 3 ]
  2. NYHA status [ Time Frame: 3 ]

Biospecimen Retention:   Samples With DNA
Serum and plasma and myocardium


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930735


Contacts
Contact: Sanjay K Prasad, MD +442073528121 s.prasad@rbht.nhs.uk
Contact: Brian Halliday, MD +442073528121 ext 8812 b.halliday@rbht.nhs.uk

Locations
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Contact: Sanjay K Prasad, MD    +442073518800    S.Prasad@rbht.nhs.uk   
Contact: Rory R O' Hanlon, MD    +442073518800    R.O'Hanlon@rbht.nhs.uk   
Principal Investigator: Sanjay K Prasad, MD         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Sanjay K Prasad, MD Royal Brompton and Harefield Foundation Trust

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
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

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