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Outcome monitoring after cardiac surgery

Outcome Monitoring After Cardiac Surgery: Cohort study with a nested randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN90204321
Enrollment
1590
Registered
2015-01-21
Start date
2016-06-03
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Cardiac surgery Surgery

Interventions

Current interventions as of 06/02/2019: The patient information leaflets (PILs) have the same text, and the text varies from 2 formats used as standard in our institution: A4 sheet with no colour and

Sponsors

University Hospitals Bristol NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Primary outcome for the Outcome Monitoring 1. MACE 2. Mortality data from the Personal Demographics Service. Primary outcomes for the nested RCT: Participant uptake in the study for each format of the information leaflet

Secondary

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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026