The Prognostic Significance of Fibrosis Detection in Card... | NCT00930735

Studies
The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

NCT00930735

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Status

Unknown status

Last Update Posted

Apr 23, 2018Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Cardiomyopathy
Coronary Artery Disease

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Apr 30, 2020Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

Jun 27, 2009

First Submission Date that Met QC Criteria

Jun 29, 2009

First Posted Date

Jun 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2018

Last Update Posted Date

Apr 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sanjay Prasad, Consultant Cardiologist, Royal Brompton & Harefield NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Royal Brompton & Harefield NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Myocardial fibrosis, outcomes		Groups with none and variable amounts of myocardial fibrosis

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All cause mortality		3 years
Ventricular arrhythmias		3 years
Unplanned heart failure admissions		3 years

Secondary Outcomes

Measure	Description	Time Frame
Ejection fraction		3
NYHA status		3

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sanjay K Prasad, MD	Contact	+442073528121		s.prasad@rbht.nhs.uk
Brian Halliday, MD	Contact	+442073528121	8812	b.halliday@rbht.nhs.uk

Overall Officials

Name	Affiliation	Role
Sanjay K Prasad, MD	Royal Brompton and Harefield Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Brompton Hospital	Recruiting	London		SW3 6NP	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34642428	Derived	Vassiliou VS, Pavlou M, Malley T, Halliday BP, Tsampasian V, Raphael CE, Tse G, Vieira MS, Auger D, Everett R, Chin C, Alpendurada F, Pepper J, Pennell DJ, Newby DE, Jabbour A, Dweck MR, Prasad SK. A novel cardiovascular magnetic resonance risk score for predicting mortality following surgical aortic valve replacement. Sci Rep. 2021 Oct 12;11(1):20183. doi: 10.1038/s41598-021-99788-7.
28351901

ID	Term
D009202	Cardiomyopathies
D003324	Coronary Artery Disease

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia