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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03798652
• Other study ID #: 247309
• Status: Recruiting
• Start date: March 3, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2018
• Source: King's College London
• Contact: Amedeo Chiribiri, Dr
• Phone: +44 (0)2071887188
• Email: Amedeo.Chiribiri[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiac Ischemia
• Cardiomyopathies
• Cardiovascular Diseases
• Coronary Artery Disease
• Ischemia
• Ischemic Cardiomyopathy
• Myocardial Ischemia

Intervention

Device:
• Research CMR scan
CMR scanning at a 3Tesla scanner at King's College London
• 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.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite of all cause death hospitalisation for heart failure		12 months
Other	6- minute walk test		12 months
Primary	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	Recovery of overall Left Ventricular ejection fraction		12 months
Secondary	Change in Left Ventricular end diastolic volume		12 months