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Assessment of Coronary Artery Disease by Hybrid PET/CT

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid PET/CT
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary artery disease, PET CT scan, Stress test, Rubidium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hybrid PET/CT

Arm Description

Outcomes

Primary Outcome Measures

The Incremental Value of Adenosine Flow Reserve by Rubidium PET to Clinically Acquired Gated Studies.
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.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2006
Last Updated
May 17, 2021
Sponsor
University of Maryland, Baltimore
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00320931
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, PET CT scan, Stress test, Rubidium

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid PET/CT
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hybrid PET/CT
Other Intervention Name(s)
Philips Gemini
Intervention Description
Rest and vasodilation stress rubidium PET and coronary angiography with CT were performed using standard doses for clinically indicated studies.
Primary Outcome Measure Information:
Title
The Incremental Value of Adenosine Flow Reserve by Rubidium PET to Clinically Acquired Gated Studies.
Description
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.
Time Frame
3-8 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasken Dilsizian, M.D.
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Assessment of Coronary Artery Disease by Hybrid PET/CT

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