In Silico Trials of Surgical Interventions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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In Silico Trials of Surgical Interventions - Using Routinely Collected Data to Model Trial Feasibility and Design Efficiency In Vivo Randomised Controlled Trials

Conditions
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Cardiovascular Diseases

Participation Criteria
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Eligibility Criteria
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- 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care<br>As recommended by treatment guidelines. | |
| Cardiovascular Intervention<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention) | As specified in the trial protocol | 1-Year | 
| Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention) | As specified in the trial protocol | 3-Year | 
| Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention) | As specified in the trial protocol | 5-Year | 
| Length of Hospital Stay | As specified in the trial protocol | 1-Year | 
| Length of Hospital Stay | As specified in the trial protocol | 3-Year | 
| Length of Hospital Stay | As specified in the trial protocol | 5-Year | 
| Rehospitalisation | As specified in the trial protocol | 1-Year | 
| Rehospitalisation | As specified in the trial protocol | 3-Year | 
| Rehospitalisation | As specified in the trial protocol | 5-Year |