Cardiovascular DiseasesNCT05853536
In Silico Trials of Surgical Interventions
An observational study of Cardiovascular Diseases, run by University of Leicester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 13,977,257 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All Adult patients (18 years and above) with cardiovascular diseases (ICD10 I00-I99) treated in NHS hospitals in England.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing,
Leicester, Leicestershire, LE3 9QP
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE) and their components
As specified in the trial protocol
Measured: 1-Year
Major adverse cardiovascular events (MACE) and their components
As specified in the trial protocol
Measured: 3-Year
Major adverse cardiovascular events (MACE) and their components
As specified in the trial protocol
Measured: 5-Year
Secondary outcomes (9)
Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)
As specified in the trial protocol
Measured: 1-Year
Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)
As specified in the trial protocol
Measured: 3-Year
Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)
As specified in the trial protocol
Measured: 5-Year
Length of Hospital Stay
As specified in the trial protocol
Measured: 1-Year
Length of Hospital Stay
As specified in the trial protocol
Measured: 3-Year
Length of Hospital Stay
As specified in the trial protocol
Measured: 5-Year
Rehospitalisation
As specified in the trial protocol
Measured: 1-Year
Rehospitalisation
As specified in the trial protocol
Measured: 3-Year
Rehospitalisation
As specified in the trial protocol
Measured: 5-Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Aug 2019
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 13,977,257 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University of Glasgow, Cornell University, Queen Mary University of London, Newcastle University, University of Bristol
- Responsible party
- Sponsor
- Investigators
- Gavin Murphy, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853536
- Sponsor's protocol ID
- 0728UE
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36350978Liao W, Rashid M, Brookes CL, Barber S, Turner RM, Gravel GM, Petrie MC, Lipsic E, Doenst T, Fremes S, Murphy GJ; High-Risk REVASC consortium. Study design for an emulated trial of a 2 arm, parallel, stratified, adaptive, RCT of CABG versus PCI in people requiring myocardial revascularization at high risk (High-Risk REVASC). Am Heart J. 2026 Jun;296:107368. doi: 10.1016/j.ahj.2026.107368. Epub 2026 Feb 2.
PubMed 41638385
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Silico Trials of Surgical Interventions - Using Routinely Collected Data to Model Trial Feasibility and Design Efficiency In Vivo Randomised Controlled Trials
- ClinicalTrials.gov ID
- NCT05853536
- Acronym / sponsor ID
- 0728UE
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13,977,257 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- King's College London, University of Glasgow, Cornell University, Queen Mary University of London, Newcastle University, University of Bristol
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All Adult patients (18 years and above) with cardiovascular diseases (ICD10 I00-I99) treated in NHS hospitals in England.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiovascular events (MACE) and their components
Time frame: 1-Year
As specified in the trial protocol
Major adverse cardiovascular events (MACE) and their components
Time frame: 3-Year
As specified in the trial protocol
Major adverse cardiovascular events (MACE) and their components
Time frame: 5-Year
As specified in the trial protocol
9 secondary outcomes
Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)
Time frame: 1-Year
Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)
Time frame: 3-Year
Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)
Time frame: 5-Year
Length of Hospital Stay
Time frame: 1-Year
Length of Hospital Stay
Time frame: 3-Year
Length of Hospital Stay
Time frame: 5-Year
Rehospitalisation
Time frame: 1-Year
Rehospitalisation
Time frame: 3-Year
Rehospitalisation
Time frame: 5-Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 36350978Pathak 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.
- Derived from this study: PubMed 41638385Liao W, Rashid M, Brookes CL, Barber S, Turner RM, Gravel GM, Petrie MC, Lipsic E, Doenst T, Fremes S, Murphy GJ; High-Risk REVASC consortium. Study design for an emulated trial of a 2 arm, parallel, stratified, adaptive, RCT of CABG versus PCI in people requiring myocardial revascularization at high risk (High-Risk REVASC). Am Heart J. 2026 Jun;296:107368. doi: 10.1016/j.ahj.2026.107368. Epub 2026 Feb 2.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gavin Murphy principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) and their components (time frame: 1-Year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853536, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.