- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00320931
Assessment of Coronary Artery Disease by Hybrid PET/CT
Assessment of Coronary Flow Reserve and CT Angiography By Hybrid PET/CT: Relation to Clinically Indicated SPECT Studies
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Hybrid PET/CT
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Rest and vasodilation stress rubidium PET and coronary angiography with CT were performed using standard doses for clinically indicated studies.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Incremental Value of Adenosine Flow Reserve by Rubidium PET to Clinically Acquired Gated Studies.
Time Frame: 3-8 minute
|
All data were acquired in list-mode for 8 minutes and retrospectively sorted into static, ECG gated and dynamic images.
Rubidium retention was calculated by dividing the late (3-8 minute) whole myocardium region-of-interest data by the integral of the input function over the first minute.
Adenosine flow reserve was estimated by dividing rubidium retention during adenosine vasodilation by the same measure at rest.
These quantitative flow and flow reserve values were compared to clinically acquired gated studies in the 30 participants.
|
3-8 minute
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vasken Dilsizian, M.D., University of Maryland, College Park
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-27314 (LR-05-003)
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