Congenital Heart DiseaseNCT02700737
Evaluation of Image-Based Modelling on Clinical Decisions in Coarctation of the Aorta
A study testing Image-based simulation modelling and Imaging parameters currently recommended by clinical practice guidelines in people with Congenital Heart Disease and Aortic Coarctation, run by London School of Economics and Political Science at 1 site in United Kingdom.
Trial summary
To answer the research question: "Would image-based modelling result in different clinical decisions as compared to clinical practice guidelines?", we will conduct a randomized controlled experiment in which we will compare the hypothetical decisions made by interventional cardiologists who are presented with imaging… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease, Aortic Coarctation, Cardiovascular Disease
- What is being tested?
- Image-based simulation modelling and Imaging parameters currently recommended by clinical practice guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Aug 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Practicing interventional cardiologists
- Has treated patients with coarctation of the aorta during the past 6 months
Who cannot join
- Participation in CARDIOPROOF trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Economics and Political Science
London
About this study
To answer the research question: "Would image-based modelling result in different clinical decisions as compared to clinical practice guidelines?", we will conduct a randomized controlled experiment in which we will compare the hypothetical decisions made by interventional cardiologists who are presented with imaging parameters currently recommended by clinical practice guidelines vs. hypothetical decisions made by interventional cardiologists receiving an expanded list of parameters, including simulation modelling.
Read the detailed description
In collaboration with our three clinical partners, we will first generate two separate imaging datasets for a maximum of three patients recruited to participate in CARDIOPROOF. The first dataset will include the imaging parameters currently recommended by clinical practice guidelines (referred to as "limited dataset"). The second dataset will include an expanded list of parameters, inclusive of information that is available from traditional imaging parameters (as recommended by the guidelines) and simulation modeling (referred to as "image-based modelling dataset").
We will generate both limited and image-based modelling datasets from fully de-identified patients already enrolled in CARDIOPROOF (NCT02591940) who have consented to publication of data in anonymized form.
Using a computerized random-sample function, we will randomly allocate interventional cardiologists into two separate groups and present them with one set of imaging data. The first group will receive a "limited" dataset including only information that is available from traditional diagnostics (as recommended by the clinical practice guidelines) for a pre-specified number of patients (maximum of 3). The second group will receive the full, detailed dataset inclusive of information that is available from traditional diagnostics (as recommended by the guidelines) and simulation modelling for the same set of patients.
We will then ask the interventional cardiologists in the two groups to make (hypothetical) clinical decisions using the dataset of imaging parameters presented to them. The clinical decisions will be hypothetical because patients will have been treated according to clinical practice guidelines and this experiment will retrospectively involve interventional cardiologists who are not directly involved in the care of the patients participating in CARDIOPROOF.
The analysis will focus on each hypothetical scenario and compare the proportions of cardiologists making different types of intervention decisions in the two randomly allocated groups.
- Being tested
- Image-based simulation modelling, Imaging parameters currently recommended by clinical practice guidelines
- Keywords
- cardiovascular modeling, aortic coarctation, virtual stenting
- Medical subject headings
- Heart Defects, Congenital, Aortic Coarctation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-based simulation modellingOther
The first dataset will include the imaging parameters currently recommended by clinical practice guidelines (referred to as "limited dataset").
Imaging parameters currently recommended by clinical practice guidelinesOther
The second dataset will include an expanded list of parameters, inclusive of information that is available from traditional imaging parameters (as recommended by the guidelines) and simulation modeling (referred to as "image-based modelling dataset").
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Interventional cardiologists presented with "limited" dataset including only information that is available from imaging parameters currently recommended by clinical practice guidelines. Receives: Other: Imaging parameters currently recommended by clinical practice guidelines |
| Group B | Experimental | Interventional cardiologists presented with the full dataset, including imaging parameters currently recommended by clinical practice guidelines and image-based simulation modelling. Receives: Other: Image-based simulation modelling; Other: Imaging parameters currently recommended by clinical practice guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision to intervene
Our primary outcome of interest in this randomized experiment will be 'decision to intervene' by cardiologists evaluating imaging data obtained from patients with aortic coarctation. Interventional cardiologists will be asked the following question:
Based on the information presented to you, would you intervene in this patient now? Please provide a yes/no answer.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Economics and Political Science
- Sponsor type
- University, hospital or other
- Collaborators
- German Heart Institute, Bambino Gesù Hospital and Research Institute, University College, London
- Responsible party
- Principal investigator, Huseyin Naci, London School of Economics and Political Science
- Investigators
- Huseyin Naci, PhD, Principal investigator, London School of Economics and Political Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700737
- Sponsor's protocol ID
- LSEHSC-01001
- Status last verified
- Oct 2016
- First submitted
- 11 Dec 2015
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Naci H, Salcher-Konrad M, Mcguire A, Berger F, Kuehne T, Goubergrits L, Muthurangu V, Wilson B, Kelm M. Impact of predictive medicine on therapeutic decision making: a randomized controlled trial in congenital heart disease. NPJ Digit Med. 2019 Mar 19;2:17. doi: 10.1038/s41746-019-0085-1. eCollection 2019.
PubMed 31304365
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Image-Based Modelling on Clinical Decisions in Coarctation of the Aorta
- ClinicalTrials.gov ID
- NCT02700737
- Acronym / sponsor ID
- LSEHSC-01001
- Keywords
- cardiovascular modeling, aortic coarctation, virtual stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- London School of Economics and Political ScienceUniversity, hospital or other
- Collaborators
- German Heart Institute, Bambino Gesù Hospital and Research Institute, University College, London
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Mar 2016 (estimated)
- 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.
To answer the research question: "Would image-based modelling result in different clinical decisions as compared to clinical practice guidelines?", we will conduct a randomized controlled experiment in which we will compare the hypothetical decisions made by interventional cardiologists who are presented with imaging parameters currently recommended by clinical practice guidelines vs. hypothetical decisions made by interventional cardiologists receiving an expanded list of parameters, including simulation modelling.
Detailed description
In collaboration with our three clinical partners, we will first generate two separate imaging datasets for a maximum of three patients recruited to participate in CARDIOPROOF. The first dataset will include the imaging parameters currently recommended by clinical practice guidelines (referred to as "limited dataset"). The second dataset will include an expanded list of parameters, inclusive of information that is available from traditional imaging parameters (as recommended by the guidelines) and simulation modeling (referred to as "image-based modelling dataset").
We will generate both limited and image-based modelling datasets from fully de-identified patients already enrolled in CARDIOPROOF (NCT02591940) who have consented to publication of data in anonymized form.
Using a computerized random-sample function, we will randomly allocate interventional cardiologists into two separate groups and present them with one set of imaging data. The first group will receive a "limited" dataset including only information that is available from traditional diagnostics (as recommended by the clinical practice guidelines) for a pre-specified number of patients (maximum of 3). The second group will receive the full, detailed dataset inclusive of information that is available from traditional diagnostics (as recommended by the guidelines) and simulation modelling for the same set of patients.
We will then ask the interventional cardiologists in the two groups to make (hypothetical) clinical decisions using the dataset of imaging parameters presented to them. The clinical decisions will be hypothetical because patients will have been treated according to clinical practice guidelines and this experiment will retrospectively involve interventional cardiologists who are not directly involved in the care of the patients participating in CARDIOPROOF.
The analysis will focus on each hypothetical scenario and compare the proportions of cardiologists making different types of intervention decisions in the two randomly allocated groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Imaging parameters currently recommended by clinical practice guidelinesInterventional cardiologists presented with "limited" dataset including only information that is available from imaging parameters currently recommended by clinical practice guidelines. |
| Group B | Experimental | Other: Image-based simulation modelling, Other: Imaging parameters currently recommended by clinical practice guidelinesInterventional cardiologists presented with the full dataset, including imaging parameters currently recommended by clinical practice guidelines and image-based simulation modelling. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Practicing interventional cardiologists
- Has treated patients with coarctation of the aorta during the past 6 months
Key exclusion criteria (1 listed)
- Participation in CARDIOPROOF trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-based simulation modellingThe first dataset will include the imaging parameters currently recommended by clinical practice guidelines (referred to as "limited dataset"). | Other | Group B |
| Imaging parameters currently recommended by clinical practice guidelinesThe second dataset will include an expanded list of parameters, inclusive of information that is available from traditional imaging parameters (as recommended by the guidelines) and simulation modeling (referred to as "image-based modelling dataset"). | Other | Group A, Group B |
Primary outcome
Decision to intervene
Time frame: Immediate
Our primary outcome of interest in this randomized experiment will be 'decision to intervene' by cardiologists evaluating imaging data obtained from patients with aortic coarctation. Interventional cardiologists will be asked the following question: Based on the information presented to you, would you intervene in this patient now? Please provide a yes/no answer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Derived from this study: PubMed 31304365Naci H, Salcher-Konrad M, Mcguire A, Berger F, Kuehne T, Goubergrits L, Muthurangu V, Wilson B, Kelm M. Impact of predictive medicine on therapeutic decision making: a randomized controlled trial in congenital heart disease. NPJ Digit Med. 2019 Mar 19;2:17. doi: 10.1038/s41746-019-0085-1. eCollection 2019.
- Overall study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Huseyin Naci, PhD principal investigator
London School of Economics and Political Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-based simulation modelling and Imaging parameters currently recommended by clinical practice guidelines in people with Congenital Heart Disease and Aortic Coarctation, run by London School of Economics and Political Science 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 31 Oct 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decision to intervene (time frame: Immediate). 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 NCT02700737, which also lists 1 linked publication.
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 31 Oct 2016.