Improved Prediction of Functional Recovery After Revascularisation Using Combined Assessment of Myocardial Ischaemia and Viability by CMR - Pilot Study
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|ClinicalTrials.gov Identifier: NCT03798652|
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases Ischemic Cardiomyopathy Cardiac Ischemia||Device: Research CMR scan Device: Research 3D transthoracic echocardiogram Other: 6-minute walk test|
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|
|Estimated Enrollment :||56 participants|
|Official Title:||Improved Prediction of Functional Recovery After Revascularisation Using Combined Assessment of Myocardial Ischaemia and Viability by CMR - Pilot Study|
|Actual Study Start Date :||March 3, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||June 30, 2022|
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.
- Recovery of the regional systolic function [ Time Frame: 12 months ]
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.
- Recovery of overall Left Ventricular ejection fraction [ Time Frame: 12 months ]
- Change in Left Ventricular end diastolic volume [ Time Frame: 12 months ]
- Composite of all cause death hospitalisation for heart failure [ Time Frame: 12 months ]
- 6- minute walk test [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798652
|Contact: Amedeo Chiribiri, Dr||+44 (0)2071887188||Amedeo.Chiribiri@kcl.ac.uk|
|Contact: Russell Franks, Dr||Russell.Franks@kcl.ac.uk|
|Principal Investigator:||Amedeo Chiribiri, Dr||King's College London|