In Silico Trials of Surgical Interventions

May 9, 2023 updated by: University of Leicester

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

13977257

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE3 9QP
        • Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leicester

Collaborators

King's College London
Queen Mary University of London
University of Bristol
Newcastle University
Cornell University
University of Glasgow

Investigators

  • Principal Investigator: Gavin Murphy, University of Leicester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0728UE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data underlying this article were provided by National Health Service Digital under licence. Raw data may be shared with permission of National Health Service Digital.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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