Perfusion Imaging and CT -Understanding Relative Efficacy (PICTURE)

General Electric (GE)

Status

Terminated

Conditions

Coronary Artery Disease

Treatments

Device: 64 Channel VCT

Study type

Interventional

Funder types

Industry

Identifiers

NCT00486447

GE-189-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

249 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.