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

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ClinicalTrials.gov Identifier: NCT01179230
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : March 23, 2015
Sponsor:
Collaborator:
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Hartford Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Myocardial Ischemia Heart Disease Other: SPECT imaging Other: PET imaging

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
Actual Enrollment : 136 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Comparison of Gated, Rest/Stress Rubidium-82 Position Emission Computed Tomography (PET) vs. Gated, Rest / Stress Technetium 99-m SPECT
Study Start Date : January 2005
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Coronary Artery Disease [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Myocardial Ischemia [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179230


Locations
United States, Alabama
The Heart Center, PC
Huntsville, Alabama, United States, 35801
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, Missouri
Cardiovascular Imaging Technologies, LLC
Kansas City, Missouri, United States, 64111
United States, North Dakota
Sanford Health Clinical Research
Fargo, North Dakota, United States, 58122-0011
United States, Ohio
Ohio Health Research Institute
Columbus, Ohio, United States, 43214
Sponsors and Collaborators
Hartford Hospital
Bracco Diagnostics, Inc
Investigators
Principal Investigator: Gary V. Heller, M.D., Ph.D. Hartford Hospital

Publications:
Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01179230     History of Changes
Other Study ID Numbers: HELL001671HE
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: July 2012

Keywords provided by Hartford Hospital:
CAD
chest pain
acute coronary syndrome
Myocardial perfusion imaging

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Dipyridamole
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents