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

NCT02700737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2016-10-31

No results posted yet for this study

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.

Conditions

Interventions

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").

Sponsors & Collaborators

  • German Heart Institute

    collaborator OTHER
  • Bambino Gesù Hospital and Research Institute

    collaborator OTHER
  • University College, London

    collaborator OTHER
  • London School of Economics and Political Science

    lead OTHER

Principal Investigators

  • Huseyin Naci, PhD · London School of Economics and Political Science

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700737 on ClinicalTrials.gov