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Trial record 1 of 1 for:    NCT00930735
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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

Tracking Information
First Submitted Date June 27, 2009
First Posted Date June 30, 2009
Last Update Posted Date April 23, 2018
Study Start Date January 2000
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 5, 2015)
  • All cause mortality [ Time Frame: 3 years ]
  • Ventricular arrhythmias [ Time Frame: 3 years ]
  • Unplanned heart failure admissions [ Time Frame: 3 years ]
Original Primary Outcome Measures
 (submitted: June 29, 2009)
  • All cause mortality [ Time Frame: 3 years ]
  • Ventricular arrhythmias [ Time Frame: 3 ]
  • Unplanned heart failure admissions [ Time Frame: 3 ]
Change History Complete list of historical versions of study NCT00930735 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 29, 2009)
  • Ejection fraction [ Time Frame: 3 ]
  • NYHA status [ Time Frame: 3 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Prognostic Significance of Fibrosis Detection in Cardiomyopathy
Official Title The Prognostic Significance of Fibrosis Detection in Ischemic and Non-ischemic Cardiomyopathy
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

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum and plasma and myocardium
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.
Condition
  • Cardiomyopathy
  • Coronary Artery Disease
Intervention Not Provided
Study Groups/Cohorts Myocardial fibrosis, outcomes
Groups with none and variable amounts of myocardial fibrosis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 29, 2009)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2025
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sanjay K Prasad, MD +442073528121 s.prasad@rbht.nhs.uk
Contact: Brian Halliday, MD +442073528121 ext 8812 b.halliday@rbht.nhs.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00930735
Other Study ID Numbers 09/0904
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sanjay Prasad, Royal Brompton & Harefield NHS Foundation Trust
Study Sponsor Royal Brompton & Harefield NHS Foundation Trust
Collaborators Not Provided
Investigators
Principal Investigator: Sanjay K Prasad, MD Royal Brompton and Harefield Foundation Trust
PRS Account Royal Brompton & Harefield NHS Foundation Trust
Verification Date April 2018