In Silico Trials of Surgical Interventions

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05853536
• Other study ID #: 0728UE
• Status: Active, not recruiting
• Start date: August 1, 2019
• Est. completion date: August 1, 2024

Study information

• Verified date: December 2022
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13977257
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
United Kingdom	Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing,	Leicester	Leicestershire

Sponsors (7)

Lead Sponsor	Collaborator
University of Leicester	Cornell University, King's College London, Newcastle University, Queen Mary University of London, University of Bristol, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events (MACE) and their components	As specified in the trial protocol	1-Year
Primary	Major adverse cardiovascular events (MACE) and their components	As specified in the trial protocol	3-Year
Primary	Major adverse cardiovascular events (MACE) and their components	As specified in the trial protocol	5-Year
Secondary	Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)	As specified in the trial protocol	1-Year
Secondary	Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)	As specified in the trial protocol	3-Year
Secondary	Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)	As specified in the trial protocol	5-Year
Secondary	Length of Hospital Stay	As specified in the trial protocol	1-Year
Secondary	Length of Hospital Stay	As specified in the trial protocol	3-Year
Secondary	Length of Hospital Stay	As specified in the trial protocol	5-Year
Secondary	Rehospitalisation	As specified in the trial protocol	1-Year
Secondary	Rehospitalisation	As specified in the trial protocol	3-Year
Secondary	Rehospitalisation	As specified in the trial protocol	5-Year

External Links

•   The results of the first emulated trial can be accessed via the link above. The study has been published by the European Heart Journal doi: 10.1093/eurheartj/ehac670