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

NCT ID: NCT03798652

Last Updated: 2019-08-19

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

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-03

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Ischemic Cardiomyopathy Cardiac Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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

Research CMR scan

Intervention Type DEVICE

CMR scanning at a 3Tesla scanner at King's College London

Research 3D transthoracic echocardiogram

Intervention Type DEVICE

The scan is required to assess left ventricular systolic function

6-minute walk test

Intervention Type OTHER

Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

Interventions

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Research CMR scan

CMR scanning at a 3Tesla scanner at King's College London

Intervention Type DEVICE

Research 3D transthoracic echocardiogram

The scan is required to assess left ventricular systolic function

Intervention Type DEVICE

6-minute walk test

Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amedeo Chiribiri, Dr

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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King's College London

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Amedeo Chiribiri, Dr

Role: CONTACT

+44 (0)2071887188

Russell Franks, Dr

Role: CONTACT

Facility Contacts

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Amedeo Chiribiri, Dr

Role: primary

+44 (0)2071887188

Russell Franks, Dr

Role: backup

+44 (0)2071887188

Other Identifiers

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247309

Identifier Type: -

Identifier Source: org_study_id

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