In Silico Trials of Surgical Interventions
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Routinely collected health data such as National Health Service Hospital Episode Statistics (HES) contains a wealth of real-world longitudinal patient health data including demographics, diagnoses, procedures and other clinical information. These data can be used to address many of the existing challenges in the design and conduct of clinical trials by optimising trial design and simplifying the assessment of adherence, safety, and outcomes. When a trial concept is initiated, researchers may use HES data to explore the hypothesis and assess trial feasibility. The large-volume patient data enables a detailed understanding of the characteristics of the target patient populations and the estimation of the real-world treatment effects across different patient groups thus enabling identification of targeted populations for specific interventions. By tapping into this resource and using advanced statistical and machine learning methods, the investigators can emulate the trial and thus obtain the key trial parameters required for designing a clinical trial, minimise the number of assumptions imputed and make the design and development of clinical trials quicker, simpler, and more reliable.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Major adverse cardiovascular events (MACE) and their components [1-Year]
As specified in the trial protocol
- Major adverse cardiovascular events (MACE) and their components [3-Year]
As specified in the trial protocol
- Major adverse cardiovascular events (MACE) and their components [5-Year]
As specified in the trial protocol
Secondary Outcome Measures
- Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention) [1-Year]
As specified in the trial protocol
- Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention) [3-Year]
As specified in the trial protocol
- Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention) [5-Year]
As specified in the trial protocol
- Length of Hospital Stay [1-Year]
As specified in the trial protocol
- Length of Hospital Stay [3-Year]
As specified in the trial protocol
- Length of Hospital Stay [5-Year]
As specified in the trial protocol
- Rehospitalisation [1-Year]
As specified in the trial protocol
- Rehospitalisation [3-Year]
As specified in the trial protocol
- Rehospitalisation [5-Year]
As specified in the trial protocol
Eligibility Criteria
Criteria
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing, | Leicester | Leicestershire | United Kingdom | LE3 9QP |
Sponsors and Collaborators
- University of Leicester
- King's College London
- University of Glasgow
- Cornell University
- Queen Mary University of London
- Newcastle University
- University of Bristol
Investigators
- Principal Investigator: Gavin Murphy, University of Leicester
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 0728UE