An interventional study of Image-based simulation modelling and Imaging parameters currently recommended by clinical practice guidelines in Congenital Heart Disease, Aortic Coarctation and Cardiovascular Disease, sponsored by London School of Economics and Political Science. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2016-10-31.
Sponsored by London School of Economics and Political Science · Not applicable, Interventional, and Health services research
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.
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 206 is above the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →London School of Economics and Political Science is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Compared within Aortic Coarctation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Defects, Congenital. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Interventional cardiologists presented with "limited" dataset including only information that is available from imaging parameters currently recommended by clinical practice guidelines.
Other: Imaging parameters currently recommended by clinical practice guidelines
Interventional cardiologists presented with the full dataset, including imaging parameters currently recommended by clinical practice guidelines and image-based simulation modelling.
Other: Image-based simulation modelling · Other: Imaging parameters currently recommended by clinical practice guidelines
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").
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.
Time frame: Immediate
Plan to share: No
The record gives a start of May 2016, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
London School of Economics and Political Science