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

October 28, 2016 updated by: Huseyin Naci, London School of Economics and Political Science
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • London School of Economics and Political Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
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
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").
Experimental: Group B
Interventional cardiologists presented with the full dataset, including imaging parameters currently recommended by clinical practice guidelines and image-based simulation modelling.
Other: 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").
Other: Image-based simulation modelling
The first dataset will include the imaging parameters currently recommended by clinical practice guidelines (referred to as "limited dataset").

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Economics and Political Science

Collaborators

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

Investigators

  • Principal Investigator: Huseyin Naci, PhD, London School of Economics and Political Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

December 11, 2015

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSEHSC-01001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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