Evaluation of Image-Based Modelling on Clinical Decisions in Coarctation of the Aorta

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.

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Key information

Conditions

Congenital Heart Disease Aortic Coarctation Cardiovascular Abnormalities Cardiovascular Disease Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London School of Economics and Political Science

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Practicing interventional cardiologists
Has treated patients with coarctation of the aorta during the past 6 months

Exclusion criteria

Participation in CARDIOPROOF trial

Treatment and study plan

Image-based simulation modelling

Other

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 guidelines

Other

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").

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

London School of Economics and Political Science

Other

Collaborators

Bambino Gesù Hospital and Research Institute
German Heart Institute
University College, London

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Mar 7, 2016
Registry last updated: Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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