Usefulness of Coronary Computed Tomography Angiography fo... | NCT02099019

Studies
Usefulness of Coronary Computed Tomography Angiography for Therapeutic Decision- Making; Revascularization

NCT02099019

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Jan 11, 2019Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Coronary Artery Disease, Ischemic Heart Disease

Interventions

Not provided

Countries

South Korea

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014Actual

Primary Completion Date

Feb 2025Estimated

Completion Date

Feb 2025Estimated

First Submitted Date

Mar 19, 2014

First Submission Date that Met QC Criteria

Mar 25, 2014

First Posted Date

Mar 28, 2014Estimated

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

Jan 9, 2019

Last Update Posted Date

Jan 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

As the prospective, observational, cross-sectional study, the accuracy of CT angiography-based therapeutic decision-making for revascularization will be evaluated. The primary objective of this study is to evaluate the accuracy of CT angiography-based therapeutic decision-making for revascularization prior to conventional angiography whether CT angiography is an accurate non-invasive technique to determine the most appropriate therapeutic strategies.

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

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of CT angiography	Sensitivity, specificity, positive predictive value, and negative predictive value for revascularization including PCI and CABG.	1day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients ≥ 20 years old
Patients who are scheduled for elective conventional coronary angiography and are undergone CT angiography prior to conventional coronary angiography.

Exclusion Criteria:

Pregnant women or women with potential childbearing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who visited the tertiary hospital for coronary angiography who are undergone CT angiography prior to conventional coronary agniography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Myeong-Ki Hong, MD, PhD	Contact	082 2 2228 8458	88458	mkhong61@yuhs.ac

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Recruiting	Seoul		120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D003327	Coronary Disease
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided