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

Coronary Artery Disease Clinical Trial

— PETvsSPECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179230
• Other study ID #: HELL001671HE
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: March 19, 2015
• Start date: January 2005
• Est. completion date: December 2012

Study information

• Verified date: July 2012
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Disease
• Myocardial Ischemia

Intervention

Other:
• SPECT imaging
Dipyridamole stress testing 0.57 mg/kg
• PET imaging
Dipyridamole stress test 0.57 mg/kg with Rubidium PET images

Locations

Country	Name	City	State
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Sanford Health Clinical Research	Fargo	North Dakota
United States	Hartford Hospital	Hartford	Connecticut
United States	The Heart Center, PC	Huntsville	Alabama
United States	Cardiovascular Imaging Technologies, LLC	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Artery Disease		30 days	No
Secondary	Myocardial Ischemia		30 days	No