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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700737
• Other study ID #: LSEHSC-01001
• Status: Completed
• Phase: N/A
• First received: December 11, 2015
• Last updated: October 28, 2016
• Start date: May 2016
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: London School of Economics and Political Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 parameters currently recommended by clinical practice guidelines vs. hypothetical decisions made by interventional cardiologists receiving an expanded list of parameters, including simulation modelling.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Practicing interventional cardiologists

• Has treated patients with coarctation of the aorta during the past 6 months

Exclusion Criteria:

• Participation in CARDIOPROOF trial

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Aortic Coarctation
• Cardiovascular Disease
• Cardiovascular Diseases
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Image-based simulation modelling
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
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").

Locations

Country	Name	City	State
United Kingdom	London School of Economics and Political Science	London

Sponsors (4)

Lead Sponsor	Collaborator
London School of Economics and Political Science	Bambino Gesù Hospital and Research Institute, German Heart Institute, University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediate	No

External Links

•   Overall study website