Assessment of Coronary Artery Disease by Hybrid PET/CT

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00320931
First received: April 28, 2006
Last updated: April 16, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: PET/CT
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Coronary Flow Reserve and CT Angiography By Hybrid PET/CT: Relation to Clinically Indicated SPECT Studies

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Comparison of Rubidium PET and SPECT parameters (ejection fraction, left ventricular end diastolic and end diastolic function volumes)
  • Comparison of wall motion scoring on Rubidium PET and SPECT
  • Comparison of magnitude of defects on Rubidium PET, SPECT and CT angiography

Estimated Enrollment: 30
Study Start Date: March 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320931

Locations
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Astellas Pharma Inc
Investigators
Principal Investigator: Vasken Dilsizian, M.D. University of Maryland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00320931     History of Changes
Other Study ID Numbers: H-27314 (LR-05-003)
Study First Received: April 28, 2006
Last Updated: April 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Coronary artery disease
PET CT scan
Stress test
Rubudium

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014