NCT04439643

Brief Summary

Develop time-to-event prediction and plaque phenotype classification models for patients with known or suspected coronary artery disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

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

Study Start

First participant enrolled

February 5, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

June 17, 2020

Last Update Submit

September 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to adverse outcome

    Develop time-to-event model for major adverse cardiac events (MACE) prediction on large retrospective cohort (and enable a prospective collection subsequent to this study). Consistent with this primary endpoint is the evaluation of all imaging-derived data that has a bearing on the diagnosis and prognosis of the subject.

    >= 2 years

Study Arms (2)

Development / training

Selected by stratified partitioning

Device: vascuCAP

Sequestered / test

Selected by stratified partitioning

Device: vascuCAP

Interventions

vascuCAPDEVICE

time to event and phenotype classification model

Development / trainingSequestered / test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Reverse chronological, all-comers, design, adjusted for demographic factors

You may qualify if:

  • Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease, which was positive for coronary atherosclerotic changes.
  • Subject must have been ≥ 18 years of age at the time of the CCTA

You may not qualify if:

  • Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
  • CCTA taken less than 3 months after deployment of new scanner
  • Subject with insufficient CCTA image quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Andrew J. Buckler, MS

    Elucid Bioimaging Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 19, 2020

Study Start

February 5, 2020

Primary Completion

February 28, 2022

Study Completion

July 30, 2022

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations