Perfusion Imaging and CT -Understanding Relative Efficacy

NCT ID: NCT00486447

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Imaging

General imaging subjects receiving CT exams

Group Type: EXPERIMENTAL

64 Channel VCT

Intervention Type: DEVICE

cardiac CT angiography exam

Interventions

64 Channel VCT

cardiac CT angiography exam

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Budoff

Role: STUDY_CHAIR

LA Biomedical Research Institute

Locations

GE Healthcare

Waukesha, Wisconsin, United States

Countries

United States

Other Identifiers

GE-189-03

Identifier Type: -

Identifier Source: org_study_id