Clinical trial NCT01179230: Rubidium-82 Position Emission Computed Tomography (PET) Versus Gated, Rest / Stress Technetium 99-m SPECT
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Heart Disease
Keywords: CAD
chest pain
acute coronary syndrome
Myocardial perfusion imaging
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Bracco Diagnostics, Inc
First posted: 2010-08-11
Enrollment: 136
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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%)

Primary outcomes:
measure: Coronary Artery Disease
timeFrame: 30 days
Secondary outcomes:
measure: Myocardial Ischemia
timeFrame: 30 days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: The Heart Center, PC
state: Alabama
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Kansas City
country: United States
facility: Cardiovascular Imaging Technologies, LLC
state: Missouri
city: Fargo
country: United States
facility: Sanford Health Clinical Research
state: North Dakota
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
Study officials:
affiliation: Hartford Hospital
name: Gary V. Heller, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bateman TM, Heller GV, McGhie AI, Friedman JD, Case JA, Bryngelson JR, Hertenstein GK, Moutray KL, Reid K, Cullom SJ. Diagnostic accuracy of rest/stress ECG-gated Rb-82 myocardial perfusion PET: comparison with ECG-gated Tc-99m sestamibi SPECT. J Nucl Cardiol. 2006 Jan-Feb;13(1):24-33. doi: 10.1016/j.nuclcard.2005.12.004.
citation: Freedman N, Schechter D, Klein M, Marciano R, Rozenman Y, Chisin R. SPECT attenuation artifacts in normal and overweight persons: insights from a retrospective comparison of Rb-82 positron emission tomography and TI-201 SPECT myocardial perfusion imaging. Clin Nucl Med. 2000 Dec;25(12):1019-23. doi: 10.1097/00003072-200012000-00014.
citation: Stewart RE, Schwaiger M, Molina E, Popma J, Gacioch GM, Kalus M, Squicciarini S, al-Aouar ZR, Schork A, Kuhl DE. Comparison of rubidium-82 positron emission tomography and thallium-201 SPECT imaging for detection of coronary artery disease. Am J Cardiol. 1991 Jun 15;67(16):1303-10. doi: 10.1016/0002-9149(91)90456-u.
citation: Go RT, Marwick TH, MacIntyre WJ, Saha GB, Neumann DR, Underwood DA, Simpfendorfer CC. A prospective comparison of rubidium-82 PET and thallium-201 SPECT myocardial perfusion imaging utilizing a single dipyridamole stress in the diagnosis of coronary artery disease. J Nucl Med. 1990 Dec;31(12):1899-905.