PARADISE: Predicting AF After Cardiac Surgery (PARADISE)

Predicting AF After Cardiac Surgery - the PARADISE Score. A Clinical Prediction Rule for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

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

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation New Onset
• Intervention / Treatment: Other: Not applicable as observational study

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 13684

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone cardiac surgery

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective; Patients admitted to Mass Brigham Hospitals for cardiac surgery from 1st January 1998 to 31st December 2020	Other: Not applicable as observational study; Not applicable as observational study
Prospective; 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	Other: Not applicable as observational study; Not applicable as observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Model discrimination (c-statistic) to predict Atrial Fibrillation in external data set	Model discrimination (c-statistic) to predict Atrial Fibrillation in external data set	Within 7 days of cardiac surgery
Model calibration (intercept) to predict Atrial Fibrillation in external data set	Model calibration (intercept) to predict Atrial Fibrillation in external data set	Within 7 days of cardiac surgery
Model calibration (slope) to predict Atrial Fibrillation in external data set	Model calibration (slope) to predict Atrial Fibrillation in external data set	Within 7 days of cardiac surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional model performance metrics to predict Atrial Fibrillation in external data set	Model positive and negative predictive values, sensitivity and specificity to predict Atrial Fibrillation in external data set	Within 7 days of cardiac surgery
Candidate risk factors for inclusion in new onset atrial fibrillation prognostic models	Candidate risk factors for inclusion in new onset atrial fibrillation prognostic models, identified through Systematic literature review and analysis of the CALIBER database using statistical and machine learning methods. For pre-operative model, the investigators will include patient information available up to the time of surgery. For the post-operative model, the investigators will also include patient information available up to 12 hours after surgery.	Within 7 days of cardiac surgery

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Brigham and Women's Hospital; University College, London; Liverpool Heart and Chest Hospital NHS Foundation Trust; Oxford University Hospitals NHS Trust; St. Bartholomew's Hospital
• Investigators: Principal Investigator: Peter Watkinson, MD, University of Oxford; Principal Investigator: Benjamin O'Brien, MD, Deutsches Herzzentrum der Charité

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac Surgery; New Onset Atrial Fibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PID15669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available due to privacy and legal implications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No