Clinical trial NCT00320931: Assessment of Coronary Artery Disease by Hybrid PET/CT
Official title: Assessment of Coronary Flow Reserve and CT Angiography By Hybrid PET/CT: Relation to Clinically Indicated SPECT Studies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
PET CT scan
Stress test
Rubidium
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2006-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The Incremental Value of Adenosine Flow Reserve by Rubidium PET to Clinically Acquired Gated Studies.
timeFrame: 3-8 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Vasken Dilsizian, M.D.
role: PRINCIPAL_INVESTIGATOR
References: