Improved Prediction of Functional Recovery After Revascularisation Using Combined Assessment of Myocardial Ischaemia and Viability by CMR - Pilot Study

The study will investigate whether a new high resolution heart Magnetic Resonance Imaging scan, combining assessment of ischemia and viability by perfusion and Late Gadolinium Enhancement -Cardiac Magnetic Resonance is superior to Late Gadolinium Enhacement imaging alone in predicting functional recovery following revascularisation.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Ischemic Cardiomyopathy; Cardiac Ischemia
• Intervention / Treatment: Device: Research CMR scan; Device: Research 3D transthoracic echocardiogram; Other: 6-minute walk test

Detailed Description

Coronary artery disease, where the heart's blood supply is restricted by narrowings or blockages, is the commonest cause of heart failure. This condition is called ischaemic cardiomyopathy. In some patients, treating these narrowings/ blockages with by-pass surgery or stents, known as "revascularisation", helps improve the pumping strength of the heart but it is currently difficult to predict which patients will benefit. The best test the investigators currently have to predict who will benefit from revascularisation is an Magnetic Resonance Imaging scan of the heart which looks for how much the heart has been scarred. Hearts with no scar usually improve after revascularisation and hearts with lots of scar usually do not. However, lots of patients fall into the middle and have moderate amounts of scar. The Magnetic Resonance Imaging scan isn't good at predicting if this group of patients will benefit from revascularisation. Revascularisation procedures, including heart by-passes, are not without risk and often require time in intensive care, several days in hospital and a long recovery period at home. If the investigators can develop a better test which is more accurate at predicting whether hearts with moderate scar will improve then they will be able to provide better care for patients by ensuring only those patients who will get benefit from revascularisation are put through the procedure.

This study will investigate whether a new high-resolution heart Magnetic Resonance Imaging scan, which looks at not only levels of scar but also the quality of blood supply, is more accurate than current MRI scans at predicting heart recovery after revascularisation in patients with moderate amounts of scar.

• Study Type: Observational
• Enrollment (Anticipated): 56

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • King's College London
    • Contact: Amedeo Chiribiri, Dr; Phone Number: +44 (0)2071887188; Email: Amedeo.Chiribiri@kcl.ac.uk
    • Contact: Russell Franks, Dr; Phone Number: +44 (0)2071887188; Email: russell.franks@kcl.ac.uk

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The patient will all the above inclusion criteria and none of the exclusion criteria will be identified from:

• Referrals for cardiac MRI scans at King's College London;
• Referrals for cardiac catheterisation at St. Thomas' Hospital;
• Outpatient clinic referrals to St. Thomas's Hospital cardiovascular services;
• Cardiovascular multi-disciolinary team meetings

Description

Inclusion Criteria:

1. Known coronary artery disease referred for isolated surgical revascularisation;
2. Wall motion abnormalities at rest in at least two adjacents segments on standard AHA model supplied by a diseased coronary artery;
3. LV EF <45%.

Exclusion Criteria:

1. Contraindications to CMR, adenosine and low-dose dobutamine;
2. GFR <30 ml/min
3. Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or Intra-aortic Ballon Pump/left ventricular assist device therapy < 72 hours prior to enrolment;
4. Sustained Ventricular Tachycardia/Ventricular Fibrillation<72 hours prior to enrolment;
5. Implantable Cardioverter Defibrilator;
6. Pregnancy;
7. Age<18 years
8. Previous established diagnosis of non ischaemic cardiomyopathy;
9. Severe concomitant valvular disease;
10. Recente acute coronary syndrome(<4 weeks prior to enrolment).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients referred for CABG; Patients with known coronary artery disease referred for isolated surgical revascularisation, who will be invited to attend our facility for a research CMR scan, a research 3D transthoracic echocardiogram and a 6 minute walk test	Device: Research CMR scan; CMR scanning at a 3Tesla scanner at King's College London; Device: Research 3D transthoracic echocardiogram; The scan is required to assess left ventricular systolic function; Other: 6-minute walk test; Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of the regional systolic function	Recovery will be defined as a reduction in average resting wall motion score equal or more than 1. The region of interest will be defined as the segments of myocardium subentended by the revascularised coronary stenosis. Segments will be considered to have been revascularised if surgical by-pass to the diseased coronary artery subtending the segment is considered successful by the surgical team at the time of surgery.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Recovery of overall Left Ventricular ejection fraction	12 months
Change in Left Ventricular end diastolic volume	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Composite of all cause death hospitalisation for heart failure	12 months
6- minute walk test	12 months

Collaborators and Investigators

• Sponsor: King's College London
• Investigators: Principal Investigator: Amedeo Chiribiri, Dr, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Viability; Perfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Ischemia; Cardiomyopathies
• Other Study ID Numbers: 247309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No