Can CCTA Technicians Provide Accurate Interpretation of F... | NCT03168269

Studies
Can CCTA Technicians Provide Accurate Interpretation of Findings in Patients Presenting to the ED in After Hours?

NCT03168269

Sponsor

Jordan Collaborating Cardiology Group

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Coronary Computed Tomographic Angiography (CCTA)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2016Actual

Primary Completion Date

Feb 25, 2016Actual

Completion Date

Feb 25, 2016Actual

First Submitted Date

Apr 29, 2017

First Submission Date that Met QC Criteria

May 25, 2017

First Posted Date

May 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2017

Last Update Posted Date

May 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coronary Computed Tomographic Angiography (CCTA)	Diagnostic Test	CCTA of coronary arteries

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients referred for elective CCTA to assess coronary artery disease

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided