Evaluation of Image-Based Modelling on Clinical Decisions in Coarctation of the Aorta
NCT ID: NCT02700737
Last Updated: 2016-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
206 participants
INTERVENTIONAL
2016-05-31
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Interventional cardiologists presented with "limited" dataset including only information that is available from imaging parameters currently recommended by clinical practice guidelines.
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").
Group B
Interventional cardiologists presented with the full dataset, including imaging parameters currently recommended by clinical practice guidelines and image-based simulation modelling.
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").
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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").
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has treated patients with coarctation of the aorta during the past 6 months
Exclusion Criteria
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
German Heart Institute
OTHER
Bambino Gesù Hospital and Research Institute
OTHER
University College, London
OTHER
London School of Economics and Political Science
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Huseyin Naci
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Huseyin Naci, PhD
Role: PRINCIPAL_INVESTIGATOR
London School of Economics and Political Science
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
London School of Economics and Political Science
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Naci H, Salcher-Konrad M, Mcguire A, Berger F, Kuehne T, Goubergrits L, Muthurangu V, Wilson B, Kelm M. Impact of predictive medicine on therapeutic decision making: a randomized controlled trial in congenital heart disease. NPJ Digit Med. 2019 Mar 19;2:17. doi: 10.1038/s41746-019-0085-1. eCollection 2019.
Related Links
Access external resources that provide additional context or updates about the study.
Overall study website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LSEHSC-01001
Identifier Type: -
Identifier Source: org_study_id