REVascularisation for Ischaemic VEntricular Dysfunctio

Not Applicable

Completed

• Conditions: Cardiology, heart failure; Circulatory System; Heart failure

• Registration Number: ISRCTN45979711
• Lead Sponsor: King's College London

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29852933 protocol (added 19/11/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36027563/ primary composite outcome of death from any cause or hospitalization for heart failure (added 22/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-20
• Study Completion: 2022-03-31
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Current inclusion criteria as of 13/08/2014:
1. LVEF =35%
2. Extensive coronary disease (BCIS-1 Jeopardy Score =6)
3. Viability in at least 4 dysfunctional segments, that can be revascularised by PCI

Previous inclusion criteria:
1. LVEF =30%
2. Extensive coronary disease (BCIS-1 Jeopardy Score =6)
3. Viable myocardium in =30% of dysfunctional segments

Exclusion Criteria

Current exclusion criteria as of 14/09/2018:
1. Myocardial infarction <4 weeks previously
2. Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or IABP/left ventricular assist device (LVAD) therapy <72 hours prior to randomisation
3. Sustained VT/VF or appropriate ICD discharges <72 hours prior to randomisation
4. Valve disease requiring intervention
5. Contraindications to PCI
6. Aged <18 years
7. eGFR < 25 ml/min, unless established on dialysis
8. Women who are pregnant
9. Previously enrolled in REVIVED-BCIS2 or current enrolment in other trial that may affect REVIVED-BCIS2 outcome data
10. Life expectancy <1 year due to non-cardiac pathology

Previous exclusion criteria as of 13/08/2014:
Specific exclusions:
1. Significant angina (=CCS class 3)
2. Myocardial infarction < 4 weeks previously

General exclusions:
1. Decompensated heart failure requiring inotropic support or IABP/LVAD therapy <72 hours prior to randomisation
2. Sustained VT/VF or appropriate ICD discharges <72 hours prior to randomisation
3. More than mild aortic stenosis or more than mild aortic regurgitation on echocardiography
4. Contra-indications to PCI
5. Age <18 years
6. eGFR < 25 ml/min, unless established on dialysis
7. Women who are pregnant
8. Previously enrolled in REVIVED or current enrolment in other study
9. Life expectancy < 1 year due to non-cardiac pathology

Previous exclusion criteria:
Specific exclusions:
1. Significant angina (=CCS class 3)
2. Myocardial infarction < 6 weeks previously

General exclusions:
1. Decompensated heart failure requiring inotropic support or IABP/LVAD therapy <72 hours prior to randomisation
2. Sustained VT/VF or appropriate ICD discharges <72 hours prior to randomisation
3. More than mild aortic stenosis or mild aortic regurgitation on echocardiography
4. Contra-indications to PCI, including contra-indications to Aspirin or Clopidogrel or Heparin
5. Age <18 years
6. Bleeding diathesis or Warfarin therapy with INR>3
7. Active internal bleeding (except menstruation)
8. Platelet count < 100,000 cells/mm3) at randomisation
9. Haemoglobin < 9 g/dl at randomisation
10. eGFR < 25 ml/min, unless established on dialysis
11. Women who are pregnant
12. Previously enrolled in REVIVED or current enrolment in other study
13. Life expectancy < 1 year due to non-cardiac pathology

Study & Design

• Study Type: Interventional
• Study Design: Not specified