Assessment of Coronary Artery Disease by Hybrid PET/CT

NCT ID: NCT00320931

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-04-30

Brief Summary

There have been many advances in the test used to look for heart disease. An example of this newer technology is the Multislice CT scan (MSCT) and Positron Emission Tomography (PET) scans.

The use of this type of combined scan may show early coronary artery disease or the degree of damaged heart muscle form a heart attack with a single exam. It may help doctors to know who might benefit from heart surgery or angioplasty to increase the blood flow to the heart. This type of detailed images has previously been available only through cardiac catheterization.

Detailed Description

Advances in Non-invasive Multislice CT Imaging: Multislice CT (MSCT) and PET imaging are becoming more widely available and more useful in cardiac assessment. MSCT provides quantification of coronary calcium as well as information about the structures of the coronary vessel walls and atherosclerotic plaques. Multiple studies have demonstrated that MSCT provides information on coronary artery stenosis comparable to that obtained from invasive coronary angiography. PET imaging provides functional data via the measurement of coronary flow reserve (CFR). CFR is a quantitative measure of the increase in coronary blood flow in response to vasodilation; normal coronary flow is able to augment by three- to four-fold; diseased coronary arteries show less ability to increase flow, i.e. less CFR. Assessment of CFR yields functional information about the significance of coronary disease and is often used clinically in conjunction with anatomic imaging to identify early atherosclerosis. There is no current data evaluating the incremental value of hybrid PET/CT assessment of CFR and coronary anatomy in relation to SPECT studies in the clinical setting.

Conditions

Coronary Artery Disease

Study Design

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

Study Groups

Hybrid PET/CT

Group Type: EXPERIMENTAL

Hybrid PET/CT

Intervention Type: DEVICE

Rest and vasodilation stress rubidium PET and coronary angiography with CT were performed using standard doses for clinically indicated studies.

Interventions

Hybrid PET/CT

Rest and vasodilation stress rubidium PET and coronary angiography with CT were performed using standard doses for clinically indicated studies.

Intervention Type: DEVICE

Other Intervention Names

Philips Gemini

Eligibility Criteria

Inclusion Criteria

• Subject must be 18 years of age or older and able to give informed consent.
• Scheduled for clinically indicated gated Adenoscan SPECT studies at the University of Maryland Medical Center or Baltimore VA Center
• Documentation from participant's health care provider indicating no objection to subject's participation in study.

Exclusion Criteria

• Hepatic; thyroid or renal disease (creatinine >1.5 or GFR < 60mL/min)
• Women of childbearing age not using medically acceptable form of contraception, pregnant or breast-feeding
• Contrast allergy
• Inability to cooperate with imaging

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

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Vasken Dilsizian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vasken Dilsizian, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

H-27314 (LR-05-003)

Identifier Type: -

Identifier Source: org_study_id