NCT02700737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

December 11, 2015

Last Update Submit

October 28, 2016

Conditions

Congenital Heart DiseaseAortic CoarctationCardiovascular Disease

Keywords

cardiovascular modelingaortic coarctationvirtual stenting

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Group B

EXPERIMENTAL

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 modellingOther: Imaging parameters currently recommended by clinical practice guidelines

Interventions

Image-based simulation modellingOTHER

The first dataset will include the imaging parameters currently recommended by clinical practice guidelines (referred to as "limited dataset").

Group B
Imaging parameters currently recommended by clinical practice guidelinesOTHER

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 AGroup B

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Participation in CARDIOPROOF trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London School of Economics and Political Science

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31304365DERIVED

Related Links

MeSH Terms

Conditions

Heart Defects, CongenitalAortic CoarctationCardiovascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Huseyin Naci, PhD

    London School of Economics and Political Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 11, 2015

First Posted

March 7, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)