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
NCT number | NCT03798652 |
Other study ID # | 247309 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 3, 2019 |
Est. completion date | June 30, 2022 |
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.
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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College London | London |
Lead Sponsor | Collaborator |
---|---|
King's College London |
United Kingdom,
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 |
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