Assessment of Coronary Artery Disease by Hybrid PET/CT

May 17, 2021 updated by: Vasken Dilsizian, University of Maryland, Baltimore

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

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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:
  • Philips Gemini

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

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: Vasken Dilsizian, M.D., University of Maryland, College Park

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

April 28, 2006

First Posted (ESTIMATE)

May 3, 2006

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-27314 (LR-05-003)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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