Outcome monitoring after cardiac surgery

Not Applicable

Completed

• Conditions: Cardiac surgery; Surgery

• Registration Number: ISRCTN90204321
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

Brief Summary

2019 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/31881927 Nested study results (added 31/12/2019) 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36535713/ (added 20/12/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-21
• Study Completion: 2024-03-26
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4069

Inclusion Criteria

Patients, aged 18 years or above, who have had cardiac surgery at the Bristol Heart Institute.

Exclusion Criteria

1. Prisoners
2. Patients unable to give consent through mental incapacity
3. Patients whose main residence is outside the UK

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome for the Outcome Monitoring<br>1. MACE<br>2. Mortality data from the Personal Demographics Service.<br><br>Primary outcomes for the nested RCT: Participant uptake in the study for each format of the information leaflet

Secondary Outcome Measures

Name	Time	Method
1. NHS resource use<br>2. Quality of life instruments - Coronary Revascularisation Outcome Questionnaire (CROQ) and/or short-form-12 (SF12) questionnaire<br>3. International normalised ratio (INR) values e.g. in participants having valve surgery or with persistent post-operative atrial fibrillation.