The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

NCT ID: NCT00930735

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2025-07-31

Brief Summary

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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

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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)

Conditions

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Cardiomyopathy Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Myocardial fibrosis, outcomes

Groups with none and variable amounts of myocardial fibrosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Sanjay Prasad

Consultant Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanjay K Prasad, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton and Harefield Foundation Trust

Locations

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Royal Brompton Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Sanjay K Prasad, MD

Role: CONTACT

+442073528121

Brian Halliday, MD

Role: CONTACT

+442073528121 ext. 8812

Facility Contacts

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Sanjay K Prasad, MD

Role: primary

+442073518800

Rory R O' Hanlon, MD

Role: backup

+442073518800

References

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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.

Reference Type DERIVED
PMID: 34642428 (View on PubMed)

Halliday BP, Gulati A, Ali A, Guha K, Newsome S, Arzanauskaite M, Vassiliou VS, Lota A, Izgi C, Tayal U, Khalique Z, Stirrat C, Auger D, Pareek N, Ismail TF, Rosen SD, Vazir A, Alpendurada F, Gregson J, Frenneaux MP, Cowie MR, Cleland JGF, Cook SA, Pennell DJ, Prasad SK. Association Between Midwall Late Gadolinium Enhancement and Sudden Cardiac Death in Patients With Dilated Cardiomyopathy and Mild and Moderate Left Ventricular Systolic Dysfunction. Circulation. 2017 May 30;135(22):2106-2115. doi: 10.1161/CIRCULATIONAHA.116.026910. Epub 2017 Mar 28.

Reference Type DERIVED
PMID: 28351901 (View on PubMed)

Dawson DK, Hawlisch K, Prescott G, Roussin I, Di Pietro E, Deac M, Wong J, Frenneaux MP, Pennell DJ, Prasad SK. Prognostic role of CMR in patients presenting with ventricular arrhythmias. JACC Cardiovasc Imaging. 2013 Mar;6(3):335-44. doi: 10.1016/j.jcmg.2012.09.012. Epub 2013 Feb 20.

Reference Type DERIVED
PMID: 23433931 (View on PubMed)

Dweck MR, Joshi S, Murigu T, Gulati A, Alpendurada F, Jabbour A, Maceira A, Roussin I, Northridge DB, Kilner PJ, Cook SA, Boon NA, Pepper J, Mohiaddin RH, Newby DE, Pennell DJ, Prasad SK. Left ventricular remodeling and hypertrophy in patients with aortic stenosis: insights from cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2012 Jul 28;14(1):50. doi: 10.1186/1532-429X-14-50.

Reference Type DERIVED
PMID: 22839417 (View on PubMed)

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. doi: 10.1016/j.jacc.2011.03.064.

Reference Type DERIVED
PMID: 21903062 (View on PubMed)

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. doi: 10.1016/j.jacc.2010.05.010. Epub 2010 Jun 25.

Reference Type DERIVED
PMID: 20688032 (View on PubMed)

Other Identifiers

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09/0904

Identifier Type: -

Identifier Source: org_study_id

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