Perfusion Imaging and CT -Understanding Relative Efficacy

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: 64 Channel VCT

• Registration Number: NCT00486447
• Lead Sponsor: GE Healthcare

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-12
• Study First Submitted QC: 2007-06-13
• Study First Posted: 2007-06-14
• Primary Completion: 2008-04
• Study Completion: 2009-12
• Results First Submitted: 2017-05-03
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-24
• Last Update Submitted: 2017-07-24
• Results First Posted: 2017-08-23
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 249

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging	64 Channel VCT	General imaging subjects receiving CT exams

Primary Outcome Measures

Name	Time	Method
Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.	through study completion, an expected average of 1 year	Number of subjects with CT for detection purposes

Secondary Outcome Measures

Name	Time	Method
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).	1 year outcomes after initial MPS exam

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Waukesha, Wisconsin, United States