Perfusion Imaging and CT -Understanding Relative Efficacy

Coronary Artery Disease Clinical Trial

— PICTURE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486447
• Other study ID #: GE-189-03
• Status: Completed
• Phase: N/A
• First received: June 12, 2007
• Last updated: March 25, 2010
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: December 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 64 Channel VCT
cardiac CT angiography exam

Locations

Country	Name	City	State
United States	GE Healthcare	Waukesha	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, Specificity, NPV of CCTA and MPS for detecting significant coronary artery disease using diagnostic catheterization for standard of truth.		Statistical performance analysis to be done upon completion of blinded reads.	No
Secondary	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	No