Rubidium-82 Position Emission Computed Tomography (PET) Versus Gated, Rest / Stress Technetium 99-m SPECT (PETvsSPECT)

March 19, 2015 updated by: Hartford Hospital

A Prospective Comparison of Gated, Rest/Stress Rubidium-82 Position Emission Computed Tomography (PET) vs. Gated, Rest / Stress Technetium 99-m SPECT

Many stress tests being done today have two parts, the stress test and the pictures of your heart. The investigators are comparing a newer technique to obtain the pictures (PET imaging) to the standard method (SPECT imaging). However, it is not known if the new test is better than the old test. It is important to have a standard to compare these tests to, and that is why people who will be getting a cardiac catheterization are being asked to participate. The information about your arteries from the cardiac catheterization will be used to judge which stress test is better. The investigators hypothesize that the newer method (PET imaging) will be more accurate than the old method (SPECT) in detecting heart disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A SPECT rest image will be obtained using a technetium based isotope. On a separate day, a Rubidium rest PET image will be obtained prior to a Dipyridamole stress test. Subjects will receive both Rubidium and technetium isotopes following the Dipyridamole stress, and will undergo first PET imaging and later SPECT imaging following the stress test. Patients will then go for cardiac catheterization as clinically ordered by their physician.

Study Type

Observational

Enrollment (Actual)

136

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
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • The Heart Center, PC
    • Connecticut
      • Hartford, Connecticut, United States, 06102-5037
        • Hartford Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Cardiovascular Imaging Technologies, LLC
    • North Dakota
      • Fargo, North Dakota, United States, 58122-0011
        • Sanford Health Clinical Research
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Ohio Health Research Institute

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with intermediate to high likelihood of CAD referred for cardiac catheterization, either on outpatient or inpatient basis

Description

Inclusion Criteria:

  • referred for clinical cardiac catheterization

Exclusion Criteria:

  • previous CABG
  • previous MI
  • Asthma or obstructive airway disease
  • Intolerance to Dipyridamole
  • Moderate to severe valvular disease
  • Cardiomyopathy - (ejection fraction less than 45%)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PET SPECT
Subjects will have both types of imaging performed, PET and SPECT
Other: SPECT imaging
Dipyridamole stress testing 0.57 mg/kg
Other Names:
  • Pharmacological stress testing
  • Myocardial perfusion imaging
  • Persantine stress test
Other: PET imaging
Dipyridamole stress test 0.57 mg/kg with Rubidium PET images
Other Names:
  • PET perfusion images
  • Rb-92
  • PET persantine stress test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coronary Artery Disease
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Myocardial Ischemia
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Hartford Hospital

Collaborators

Bracco Diagnostics, Inc

Investigators

  • Principal Investigator: Gary V. Heller, M.D., Ph.D., Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2005

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 8, 2010

First Submitted That Met QC Criteria

August 9, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Estimate)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HELL001671HE

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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