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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00783302
First received: October 30, 2008
Last updated: December 9, 2014
Last verified: December 2014
  Purpose

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.


Condition
Coronary Artery Disease (CAD)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Multi-Center Registry Study for Clinical Outcome in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Registry Study)

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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.



Enrollment: 885
Study Start Date: September 2008
Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient suspected of having coronary artery disease or CAD.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783302

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Rubin Sheng, M.D. GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00783302     History of Changes
Other Study ID Numbers: GE-012-096
Study First Received: October 30, 2008
Results First Received: November 4, 2014
Last Updated: December 9, 2014
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by GE Healthcare:
CAD
Visipaque
CCTA

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 29, 2015