Assessment of Coronary Artery Disease by Hybrid PET/CT
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hybrid PET/CT
|
Device: Hybrid PET/CT
Rest and vasodilation stress rubidium PET and coronary angiography with CT were performed using standard doses for clinically indicated studies.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The Incremental Value of Adenosine Flow Reserve by Rubidium PET to Clinically Acquired Gated Studies. [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.
Eligibility Criteria
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
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Contrast allergy
-
Inability to cooperate with imaging
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- University of Maryland, Baltimore
- Astellas Pharma Inc
Investigators
- Principal Investigator: Vasken Dilsizian, M.D., University of Maryland, College Park
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-27314 (LR-05-003)
Study Results
Participant Flow
| Recruitment Details | The recruitment period was from 2006 to 2008 at the University of Maryland Medical Center |
|---|---|
| Pre-assignment Detail | Enrolled participants who were claustrophobic did not complete the studies |
| Arm/Group Title | Hybrid PET/CT |
|---|---|
| Arm/Group Description | The participants underwent rest and vasodilator rubidium PET and CT angiography studies using standard doses for clinically indicated studies |
| Period Title: Overall Study | |
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Subjects Undergoing Imaging Studies |
|---|---|
| Arm/Group Description | |
| Overall Participants | 30 |
| Age (over 18 years) [Mean (Full Range) ] | |
| Mean (Full Range) [over 18 years] |
30
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
33.3%
|
| Male |
20
66.7%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This study was terminated and the hybrid PET/CT scanner that was available to use for the study at the University of Maryland Medical Center was unable to generate quantitatively accurate absolute myocardial blood flow values. As such, we were unable to have scientifically accurate results and data to report. |
| Arm/Group Title | Subjects Undergoing Imaging Studies |
|---|---|
| Arm/Group Description | |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Subjects Undergoing Imaging Studies | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Subjects Undergoing Imaging Studies | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Subjects Undergoing Imaging Studies | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Subjects Undergoing Imaging Studies | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Vasken Dilsizian, MD |
|---|---|
| Organization | University of Maryland, Baltimore |
| Phone | 410-328-6890 |
| vdilsizian@umm.edu |
- H-27314 (LR-05-003)