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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00783302

Enrollment

885

Registered

2008-10-31

Start date

2008-09-30

Completion date

2011-04-30

Last updated

2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease (CAD)

Keywords

CAD, Visipaque, CCTA

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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).	Within 1 month, 6 months and 12 months post contrast administration.	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.
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).	Within 1 month, 6 months and 12 months post contrast administration.	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.
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).	Within 1 month, 6 months and 12 months post contrast administration.	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.
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).	Within 1 month, 6 months and 12 months post contrast administration.	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.

Secondary

Measure	Time frame	Description
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.	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.

Countries

United States

Participant flow

Pre-assignment details

885 subjects enrolled in the Study. 874 subjects are in the safety population where adverse event data was collected, 857 subjects are in the efficacy population. 850 subjects completed the study. 35 subjects discontinued the study.

Participants by arm

Arm	Count
Arm 1: Visipaque Injection x 320mgI/mL Injection of Visipaque at a concentration of 320mg I /mL.	874
Total	874

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	17
Overall Study	Physician Decision	1
Overall Study	Protocol Violation	3
Overall Study	Technical Problems	11
Overall Study	Withdrawal by Subject	3

Baseline characteristics

Characteristic	Arm 1: Visipaque Injection x 320mgI/mL
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	306 Participants
Age, Categorical Between 18 and 65 years	568 Participants
Age, Continuous	58.8 years STANDARD_DEVIATION 11.96
Region of Enrollment Canada	138 participants
Region of Enrollment United States	736 participants
Sex: Female, Male Female	431 Participants
Sex: Female, Male Male	443 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 874
serious Total, serious adverse events	8 / 874

Outcome results

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.