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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)

A multicentre randomised trial of surgical versus percutaneous revascularisation of ischaemic left ventricular dysfunction (iLVSD) in the United Kingdom, with embedded internal pilot and health economic analysis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN29654606
Enrollment
630
Registered
2024-07-17
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure Circulatory System

Interventions

Following baseline assessment participants will be chosen at random (randomised by a computer randomisation system, 1:1 method) to undergo revascularisation either via percutaneous angioplasty and ste

Sponsors

University of Leicester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. LVEF 6 on recent (<6 months) coronary angiogram 4. Signed informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Survival time from all-cause mortality and cardiovascular hospitalisation measured using patient records

Secondary

MeasureTime frame
Measured using patient records unless noted otherwise: 1. Overall survival time (all-cause) 2. Cardiovascular survival time 3. Time to first cardiovascular hospitalisation 4. Time to first heart failure hospitalisation 5. Time to first non-procedural myocardial infarction 6. Time to first revascularisation following assigned treatment with PCI or CABG 7. Time to stroke 8. Days Alive and Out of Hospital at 90-and 365-days 9. The number of total (first and recurrent) cardiovascular hospitalisations and heart failure hospitalisations 10. Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, discharge, 3 months, 6 months and then every 6 months until end of trial follow-up 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 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

Countries

England, Northern Ireland, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026