NCT00783302

Brief Summary

To assess prognostic value of CCTA examination in subjects who undergo CCTA as part of their medical care when compared to a standard of truth, i.e. subject outcomes during each follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
885

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

December 11, 2014

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

October 30, 2008

Results QC Date

November 4, 2014

Last Update Submit

December 9, 2014

Conditions

Coronary Artery Disease (CAD)

Keywords

CADVisipaqueCCTA

Outcome Measures

Primary Outcomes (4)

  • The Sensitivity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Predicting Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).

    Statistical analysis of the Sensitivity of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT. The results are calculated as percentage of participants.

    Within 1 month, 6 months and 12 months post contrast administration.

  • The Positive Predictive Value (PPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).

    Statistical analysis of the Positive Predictive Value (PPV) of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.

    Within 1 month, 6 months and 12 months post contrast administration.

  • The Specificity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).

    Statistical analysis of the Specificity of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.

    Within 1 month, 6 months and 12 months post contrast administration.

  • The Negative Predictive Value (NPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).

    Statistical analysis of the Negative Predictive Value (NPV) of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.

    Within 1 month, 6 months and 12 months post contrast administration.

Secondary Outcomes (1)

  • Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.

    Within 1 month, 6 months and 12 months post contrast administration.

Eligibility Criteria

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

Patient suspected of having coronary artery disease or CAD.

You may qualify if:

  • The subject is over 18 years old, exhibits chest pain syndrome and is scheduled to undergo a VISIPAQUE-enhanced CCTA examination for one of the following reasons:- Intermediate pre-test probability of CAD.
  • An uninterruptible/equivocal stress test (exercise, perfusion, or stress echo).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Paul Gordon, PhD
Organization
GE Healthcare
paul.gordon@ge.com
011-47-2318-5822

Study Officials

  • Rubin Sheng, M.D.

    GE Healthcare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2008

First Posted

October 31, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2010

Study Completion

April 1, 2011

Last Updated

December 11, 2014

Results First Posted

December 11, 2014

Record last verified: 2014-12

Locations

US(1)