Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care

Coronary Artery Disease (CAD) Clinical Trial

Official title:

A Prospective, Multi-Center Registry Study for Clinical Outcome in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Registry Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783302
• Other study ID #: GE-012-096
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: December 9, 2014
• Start date: September 2008
• Est. completion date: April 2011

Study information

• Verified date: December 2014
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 885
• Est. completion date: April 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Secondary	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.	The number of subjects in the efficacy population developing 1 or more positive and negative cardiac clinical outcomes at 1 month, 6 months, and 12 months after undergoing a Coronary Computed Tomography Angiography (CCTA) examination using Visipaque. Clinical outcomes are independent of any serious adverse events and adverse events associated with the drug administration.; This outcome measure is not reporting those subjects with serious adverse events and adverse events associated with the drug administration.	Within 1 month, 6 months and 12 months post contrast administration.	No