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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hartford Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01179230
First received: June 8, 2010
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention
Coronary Artery Disease
Myocardial Ischemia
Heart Disease
Other: SPECT imaging
Other: PET imaging

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Coronary Artery Disease [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myocardial Ischemia [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: January 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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%)
  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: 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
  More Information

Publications:
Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01179230     History of Changes
Other Study ID Numbers: HELL001671HE
Study First Received: June 8, 2010
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 11, 2014