PARADISE: Predicting AF After Cardiac Surgery

University of Oxford

Status: Active, not recruiting

Conditions: Atrial Fibrillation New Onset

Treatments: Other: Not applicable as observational study

Study type: Observational

Funder types: Other

Identifiers

NCT05255224

PID15669

Details and patient eligibility

About

The PARADISE study aims to develop and validate prediction tools to identify patients at risk of Atrial Fibrillation (AF) after cardiac surgery.

Full description

Atrial Fibrillation (AF) is a common abnormal heart rhythm. AF causes the heart to beat irregularly and sometimes very rapidly. About 30-50% of patients develop AF after heart surgery. These patients stay longer on the Intensive Care Unit (ICU) after surgery, are more likely to develop complications and have a higher risk of dying. Avoiding AF is important.

Some drugs, including beta blockers and amiodarone may help prevent AF if given after surgery. However, these may also lead to complications (such as lung damage). It is therefore important to identify which patients are most likely to benefit from these treatments (i.e., where the benefits outweigh the risks). There are existing tools designed to predict the risk of suffering AF after heart surgery. However, they are unreliable and therefore not used in clinical practice. A modern, reliable risk prediction tool is needed.

The PARADISE study will develop and test new prediction tools to identify which patients are most at risk of developing AF after heart surgery. The investigators will focus our tools on those patients who most commonly develop AF, such as those who have had surgery to repair a valve or blood vessel in their heart.

To do this the investigators will:

• Review the medical literature and assemble a panel of medical experts to create a list of known factors that affect patients' risk of AF after heart surgery
• Use a large UK general practice database (CALIBER) to see whether the investigators can find new risk factors.
• Ask the expert panel to agree a list of known and new risks factors to be included in the prediction tool.
• Develop two new prediction tools using an existing American cardiac surgery database (the Partners research Database). The first will be used before surgery, the second immediately following surgery. Two models are needed as events during surgery may alter the risk of AF.
• Test how reliably our new tools predict which patients suffer AF after surgery, with data from large UK (United Kingdom) NHS (National Health Service) heart centres, one US Hospital (Brigham) and a UK clinical trial (Tight-K).
• The investigators will work with two charities (AF Alliance and StopAfib) to share our results with patients and the wider public.

Enrollment: 13,684 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years or over
• Admitted to hospital for any cardiac surgery

Exclusion criteria

• Patients who have requested that their data not be used for research (e.g. NHS Opt-out)

Trial design

13,684 participants in 2 patient groups

Retrospective

Description:

Patients admitted to Mass Brigham Hospitals for cardiac surgery from 1st January 1998 to 31st December 2020

Treatment:

Other: Not applicable as observational study

Prospective

Description:

Patients admitted to Barts Health, Liverpool Heart and Chest Hospital, or Oxford University Hospitals NHS Foundation Trust for cardiac surgery between 1st October 2021 to 31st July 2023

Treatment:

Other: Not applicable as observational study