Clinical trial NCT00486447: Perfusion Imaging and CT -Understanding Relative Efficacy
Official title: A Prospective Multi-center Study Comparing Cardiac Computed Tomography (CT) Using a 64-detector Row Volumetric Computed Tomography (VCT) Scanner for the Detection of Coronary Artery Disease With Cardiac Radionuclide Imaging.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2007-06-14
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.

Detailed description: This study is a prospective, multi-center, within-subject comparative study. One hundred fifty (150) subjects with CATH procedures are needed in the study. Approximately 300 subjects who meet all of the inclusion/exclusion criteria will be enrolled. The study population will consist of subjects with symptoms suspected of and at intermediate-risk for ischemic heart disease, which are referred for MPS for a definitive diagnosis of CAD.

Each subject will undergo the following procedures:

* A Myocardial Perfusion Study (MPS) procedure, as standard of care;
* An IV contrast-enhanced cardiac CT (CCTA) procedure;
* A CATH procedure when the MPS and/or cardiac CT examination is deemed positive or equivocal and at the discretion of the referring physicians, as a standard-of-care procedure.

When both the MPS and CCTA are normal, the subject is not required to undergo a CATH procedure, but will enter into follow-up. The research staff at each site will perform follow-up for each subject at 12 months (± 15 days) and 24 months (± 15 days) and 36 months (± 15 days) after the completion of the cardiac CT procedure.

Eligibility criteria: Inclusion Criteria:

* Patients with an intermediate probability risk for coronary artery disease.
* Subject has symptoms of suspected ischemic heart disease.
* Subject is at intermediate risk for coronary artery disease

Exclusion Criteria:

* The subject has undergone a prior CCTA within 6 months prior to entering the study.
* The subject has a documented history of CAD by CATH, myocardial infarction (MI), metal stent placement in any of the coronary vessels, or a previous coronary artery bypass graft (CABG) procedure
* The subject has hemodynamic or active clinical instability:

  * Acute chest pain (sudden onset);
  * Cardiac shock;
  * Unstable blood pressure (BP);
  * Severe congestive heart failure or acute pulmonary edema.

Primary outcomes:
measure: Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.
timeFrame: through study completion, an expected average of 1 year
Secondary outcomes:
measure: Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death).
timeFrame: 1 year outcomes after initial MPS exam
Other outcomes:
Locations:
city: Waukesha
country: United States
facility: GE Healthcare
state: Wisconsin
Study officials:
affiliation: LA Biomedical Research Institute
name: Matthew Budoff
role: STUDY_CHAIR
References: