In Silico Trials of Surgical Interventions

NCT05853536 | Unknown

• 1 other identifier: 0728UE
• Study Type: observational
• Target: 13,977,257
• Locations: 1 country
• Sites: 1

Brief Summary

The project aims to establish a database of cardiovascular patients using HES and linked mortality data. This database will be used to model trials in silico with the aim of informing the design of future cardiovascular trials in the United Kingdom.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (3)

• Major adverse cardiovascular events (MACE) and their components

  As specified in the trial protocol

  1-Year

• Major adverse cardiovascular events (MACE) and their components

  As specified in the trial protocol

  3-Year

• Major adverse cardiovascular events (MACE) and their components

  As specified in the trial protocol

  5-Year

Secondary Outcomes (9)

• Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)

  1-Year

• Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)

  3-Year

• Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)

  5-Year

• Length of Hospital Stay

  1-Year

• Length of Hospital Stay

  3-Year

Study Arms (2)

Standard of Care

As recommended by treatment guidelines.

Cardiovascular Intervention

Examples include: * Cardiac surgery - Coronary artery bypass grafting (CABG), Repair and replacement of heart valve and other cardiovascular surgery including surgery on the thoracic aorta. * On-pump / off-pump / minimally invasive bypass. * Open / Transcatheter approach for valve replacement or repair. * Open versus minimally invasive valve repair/ replacement. * Procedural coronary revascularization Percutaneous Coronary Intervention. * Closure of the left atrial appendage.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Adult patients (18 years and above) with cardiovascular diseases (ICD10 I00-I99) treated in NHS hospitals in England.

\- The target trial protocol will be used to develop an emulated trial protocol, which will give the best approximation of the trial protocol, given the limitations and constraints of the observational data. To mimic an actual trial population, the target trial population will be matched with individual patient data from a historical trial, targeting the same population.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Leicester: lead
• King's College London: collaborator
• University of Glasgow: collaborator
• Cornell University: collaborator
• Queen Mary University of London: collaborator
• Newcastle University: collaborator
• University of Bristol: collaborator

Study Sites (1)

Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing,

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Related Publications (2)

• Pathak S, Lai FY, Miksza J, Petrie MC, Roman M, Murray S, Dearling J, Perera D, Murphy GJ. Surgical or percutaneous coronary revascularization for heart failure: an in silico model using routinely collected health data to emulate a clinical trial. Eur Heart J. 2023 Feb 1;44(5):351-364. doi: 10.1093/eurheartj/ehac670.

  PMID: 36350978 BACKGROUND

• Liao W, Rashid M, Brookes CL, Barber S, Turner RM, Gravel GM, Petrie MC, Lipsic E, Doenst T, Fremes S, Murphy GJ; High-Risk REVASC consortium. Study design for an emulated trial of a two arm, parallel, stratified, adaptive, RCT of CABG versus PCI in people requiring myocardial revascularisation at high risk (High-Risk REVASC). Am Heart J. 2026 Feb 2:107368. doi: 10.1016/j.ahj.2026.107368. Online ahead of print.

  PMID: 41638385 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Gavin Murphy

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: May 10, 2023
• Study Start: August 1, 2019
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: May 10, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)