Assessment of Coronary Artery Disease by Hybrid PET/CT

NCT00320931 | Terminated Results DMC

• 1 other identifier: H-27314 (LR-05-003)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; PET CT scan; Stress test; Rubidium

Outcome Measures

Primary Outcomes (1)

• 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.

  3-8 minute

Study Arms (1)

Hybrid PET/CT

EXPERIMENTAL

Device: Hybrid PET/CT

Interventions

Hybrid PET/CT DEVICE

Rest and vasodilation stress rubidium PET and coronary angiography with CT were performed using standard doses for clinically indicated studies.

Also known as: Philips Gemini

Hybrid PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

For rubidium PET, statistical noise in static or gated images and quantitative accuracy in early-phase dynamic images could not be simultaneously optimized on the hybrid PET/CT scanner.

Results Point of Contact

• Title: Vasken Dilsizian, MD
• Organization: University of Maryland, Baltimore

vdilsizian@umm.edu

410-328-6890

Study Officials

• Vasken Dilsizian, M.D.

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 9, 2021
• Results First Posted: June 9, 2021

Record last verified: 2021-05

Locations

US (1)