In Silico Trials of Surgical Interventions

Active, not recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT05853536
• Lead Sponsor: University of Leicester

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.

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 Timeline

• Study Start: 2019-08-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10
• Primary Completion: 2023-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 13977257

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events (MACE) and their components	5-Year	As specified in the trial protocol

Secondary Outcome Measures

Name	Time	Method
Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)	5-Year	As specified in the trial protocol
Length of Hospital Stay	5-Year	As specified in the trial protocol
Rehospitalisation	5-Year	As specified in the trial protocol

Trial Locations

Locations (1)

Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing,; 🇬🇧 Leicester, Leicestershire, United Kingdom