Randomised controlled multi centre trial comparing two standard of care revascularisation treatments, either percutaneous angioplasty and stents (PCI) or coronary artery bypass grafting (CABG), in patients who have been diagnosed with a condition that reduces heart function known as ischaemic left ventricular dysfunction (ilSVD) as well as coronary artery disease (CAD)

Not Applicable

• Conditions: Heart failure; Circulatory System

• Registration Number: ISRCTN29654606
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-17
• Last Update Posted: 29 July 2024
• Study Completion: 2032-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

1. Age >18 years
2. LVEF <40% (quantified by any recognised imaging modality) within the last 12 months. If the patient has had an MI within the last 12 months post-MI imaging is required with LVEF <40%
3. Significant amount of myocardium at risk defined as coronary artery disease with BCIS myocardial jeopardy score >6 on recent (<6 months) coronary angiogram
4. Signed informed consent

Exclusion Criteria

1. Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or mechanical circulatory support less than 48 hours prior to randomisation
2. ST Elevation Myocardial Infarction (STEMI) <72 hours
3. Valvular heart disease or any other cardiac conditions (e.g., LV aneurysm) requiring surgery
4. Pregnancy
5. Individuals who have declined access to Hospital Episode Statistics for research purposes
6. An inability to understand the languages in which the trial materials are provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival time from all-cause mortality and cardiovascular hospitalisation measured using patient records

Secondary Outcome Measures

Name	Time	Method
Measured using patient records unless noted otherwise:<br>1. Overall survival time (all-cause)<br>2. Cardiovascular survival time <br>3. Time to first cardiovascular hospitalisation<br>4. Time to first heart failure hospitalisation<br>5. Time to first non-procedural myocardial infarction <br>6. Time to first revascularisation following assigned treatment with PCI or CABG<br>7. Time to stroke<br>8. Days Alive and Out of Hospital at 90-and 365-days<br>9. The number of total (first and recurrent) cardiovascular hospitalisations and heart failure hospitalisations<br>10. Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, discharge, 3 months, 6 months<br>and then every 6 months until end of trial follow-up<br>11. Seattle Angina Questionnaire-7 (SAQ-7) at baseline, discharge, 3 months, 6 months, and then every 6 months until end of trial follow-up<br>12. Quality of life measured by the EQ-5D-5L questionnaire at baseline, 3 months, 6 months and annually until end of trial follow-up