Coronary Artery Disease (CAD)NCT00783302

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

An observational study of Coronary Artery Disease (CAD), run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease (CAD)
How many people: 885 participants
Where: 1 siteUnited States
Study dates: Sep 2008to Apr 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patient suspected of having coronary artery disease or CAD.

Who may be able to join

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).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

GE Healthcare
Princeton, New Jersey, 08540

Other trials in United States

About this study

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

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.

Conditions: Coronary Artery Disease (CAD)
Keywords: CAD, Visipaque, CCTA
Medical subject headings: Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Apr 2011

First posted31 Oct 2008 (estimated)
Study startSep 2008
Primary completionOct 2010
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 885 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00783302
Sponsor's protocol ID: GE-012-096
Status last verified: Dec 2014
First submitted: 30 Oct 2008
Last updated: 11 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease (CAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center Registry Study for Clinical Outcome in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Registry Study)
ClinicalTrials.gov ID: NCT00783302
Acronym / sponsor ID: GE-012-096
Conditions: Coronary Artery Disease (CAD)
Keywords: CAD, Visipaque, CCTA
Study type: Observational
Recruitment status: Completed
Enrolment: 885 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Oct 2010 (actual)
Study completion: Apr 2011 (actual)
First posted: 31 Oct 2008 (estimated)
Results: Posted 11 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patient suspected of having coronary artery disease or CAD.

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 11 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Visipaque Injection x 320mgI/mL	885	850

Primary outcome: 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).

Time frame: Within 1 month, 6 months and 12 months post contrast administration.. Number (95% Confidence Interval). Unit: Percentage of Subjects

Measure	Sensitivity - Subject Follow-up Period 1 Month n = 51	Sensitivity - Subject Follow-up Period 6 Months n = 71	Sensitivity - Subject Follow-up Period 12 Months n = 76
Value	96.1 (86.5 to 99.5)	95.8 (88.1 to 99.1)	94.7 (87.1 to 98.5)

Population analysed: The subject follow-up period went from 1 month, 6 months and 12 months.

Primary outcome: 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).

Time frame: Within 1 month, 6 months and 12 months post contrast administration.. Number (95% Confidence Interval). Unit: Percentage of Subjects

Measure	Positive Predictive Value - Subject Follow-up Period 1 Month n = 174	Positive Predictive Value - Subject Follow-up Period 6 Months n = 173	Positive Predictive Value - Subject Follow-up Period 12 Months n = 172
Value	28.2 (21.6 to 35.5)	39.3 (32.0 to 47.0)	41.9 (34.4 to 49.6)

Primary outcome: 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).

Time frame: Within 1 month, 6 months and 12 months post contrast administration.. Number (95% Confidence Interval). Unit: Percentage of Subjects

Measure	Specificity - Subject Follow-up Period 1 Month n = 806	Specificity - Subject Follow-up Period 6 Months n = 782	Specificity - Subject Follow-up Period 12 Months n = 767
Value	84.5 (81.8 to 86.9)	86.6 (84.0 to 88.9)	87.0 (84.4 to 89.3)

Primary outcome: 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).

Time frame: Within 1 month, 6 months and 12 months post contrast administration.. Number (95% Confidence Interval). Unit: Percentage of Subjects

Measure	Negative Predictive Value - Subject Follow-up Period 1 Month n = 683	Negative Predictive Value - Subject Follow-up Period 6 Months n = 680	Negative Predictive Value - Subject Follow-up Period 12 Months n = 671
Value	99.7 (98.9 to 100.0)	99.6 (98.7 to 99.9)	99.4 (98.5 to 99.8)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Visipaque Injection x 320mgI/mL	8 of 874 (0.9%)	0 of 874 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rubin Sheng, M.D. principal investigator

GE Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease (CAD), run by GE Healthcare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Within 1 month, 6 months and 12 months post contrast administration.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00783302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.