The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

The Prognostic Significance of Fibrosis Detection in Ischemic and Non-ischemic Cardiomyopathy

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Cardiomyopathy

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
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Sanjay K Prasad, MD; Phone Number: +442073528121; Email: s.prasad@rbht.nhs.uk
• Study Contact Backup: Name: Brian Halliday, MD; Phone Number: 8812 +442073528121; Email: b.halliday@rbht.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Recruiting
    • Royal Brompton Hospital
    • Contact: Sanjay K Prasad, MD; Phone Number: +442073518800; Email: S.Prasad@rbht.nhs.uk
    • Contact: Rory R O' Hanlon, MD; Phone Number: +442073518800; Email: R.O'Hanlon@rbht.nhs.uk
    • Principal Investigator: Sanjay K Prasad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Ejection fraction	3
NYHA status	3

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Investigators: Principal Investigator: Sanjay K Prasad, MD, Royal Brompton and Harefield Foundation Trust

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: June 27, 2009
• First Submitted That Met QC Criteria: June 29, 2009
• First Posted (Estimate): June 30, 2009

Study Record Updates

• Last Update Posted (Actual): April 23, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Cardiomyopathies
• Other Study ID Numbers: 09/0904