NCT03168269

Brief Summary

Coronary Computed Tomographic Angiography (CCTA) is emerging as the diagnostic test of choice in chest pain patients with low to intermediate probability of coronary artery disease (CAD). Qualified CCTA readers may not be available around the clock in most centers, limiting the use of CCTA. This study aimed to determine if well-qualified CCTA technicians can provide initial accurate diagnosis to guide initial management and triage of such patients

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

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

January 27, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

29 days

First QC Date

April 29, 2017

Last Update Submit

May 25, 2017

Conditions

Keywords

CCTA interpretationtechniciansexpertscomparison

Outcome Measures

Primary Outcomes (1)

  • The agreements between the two technicians and the cardiologist in evaluation of coronary segments

    All coronary segments are independently assesses for CAD by the two technicians and the expert cardiologist

    24 hours

Interventions

CCTA of coronary arteries

Eligibility Criteria

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

All patients referred from the ED or outpatient service for elective CCTA to rule out CAD

You may qualify if:

  • All patients referred for elective CCTA to assess coronary artery disease

You may not qualify if:

  • Patients with previous coronary revascularization procedures (PCI or CABG).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2017

First Posted

May 30, 2017

Study Start

January 27, 2016

Primary Completion

February 25, 2016

Study Completion

February 25, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05