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

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

Study Description

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 Design

• 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
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Myocardial Ischemia [ Time Frame: 30 days ]

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• 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%)

Contacts and Locations

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:

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.

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.

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.

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.

• Responsible Party: Hartford Hospital
• ClinicalTrials.gov Identifier: NCT01179230
• Other Study ID Numbers: HELL001671HE
• First Posted: August 11, 2010
• 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; Heart Diseases; Ischemia; Coronary Disease; 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