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

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ClinicalTrials.gov Identifier: NCT02700737
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : October 31, 2016
Sponsor:
Collaborators:
German Heart Institute
Bambino Gesù Hospital and Research Institute
University College, London
Information provided by (Responsible Party):
Huseyin Naci, London School of Economics and Political Science

Brief 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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Aortic Coarctation Cardiovascular Disease Other: Image-based simulation modelling Other: Imaging parameters currently recommended by clinical practice guidelines Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Image-Based Modelling on Clinical Decisions in Coarctation of the Aorta
Study Start Date : May 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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: Image-based simulation modelling
The first dataset will include the imaging parameters currently recommended by clinical practice guidelines (referred to as "limited dataset").

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").




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Participation in CARDIOPROOF trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700737


Locations
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United Kingdom
London School of Economics and Political Science
London, United Kingdom
Sponsors and Collaborators
London School of Economics and Political Science
German Heart Institute
Bambino Gesù Hospital and Research Institute
University College, London
Investigators
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Principal Investigator: Huseyin Naci, PhD London School of Economics and Political Science

Additional Information:
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Responsible Party: Huseyin Naci, Assistant Professor, London School of Economics and Political Science
ClinicalTrials.gov Identifier: NCT02700737     History of Changes
Other Study ID Numbers: LSEHSC-01001
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Huseyin Naci, London School of Economics and Political Science:
cardiovascular modeling
aortic coarctation
virtual stenting

Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities