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

NCT01179230 | Completed

• 1 other identifier: HELL001671HE
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 5

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia; Heart Disease

Keywords

CAD; chest pain; acute coronary syndrome; Myocardial perfusion imaging

Outcome Measures

Primary Outcomes (1)

• Coronary Artery Disease

  30 days

Secondary Outcomes (1)

• Myocardial Ischemia

  30 days

Study Arms (1)

PET SPECT

Subjects will have both types of imaging performed, PET and SPECT

Other: SPECT imaging; Other: PET imaging

Interventions

SPECT imaging OTHER

Dipyridamole stress testing 0.57 mg/kg

Also known as: Pharmacological stress testing, Myocardial perfusion imaging, Persantine stress test

PET SPECT

PET imaging OTHER

Dipyridamole stress test 0.57 mg/kg with Rubidium PET images

Also known as: PET perfusion images, Rb-92, PET persantine stress test

PET SPECT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• referred for clinical cardiac catheterization

You may not qualify if:

• previous CABG
• previous MI
• Asthma or obstructive airway disease
• Intolerance to Dipyridamole
• Moderate to severe valvular disease
• Cardiomyopathy - (ejection fraction less than 45%)

Sponsors & Collaborators

• Hartford Hospital: lead
• Bracco Diagnostics, Inc: collaborator

Study Sites (5)

The Heart Center, PC

Huntsville, Alabama, 35801, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Cardiovascular Imaging Technologies, LLC

Kansas City, Missouri, 64111, United States

Location

Sanford Health Clinical Research

Fargo, North Dakota, 58122-0011, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Related 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. doi: 10.1016/j.nuclcard.2005.12.004.

  PMID: 16464714 BACKGROUND

• 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.

  PMID: 11129138 BACKGROUND

• 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.

  PMID: 2042560 BACKGROUND

• 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.

  PMID: 2266384 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Chest Pain; Acute Coronary Syndrome

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Coronary Disease; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Gary V. Heller, M.D., Ph.D.

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: August 11, 2010
• Study Start: January 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 23, 2015

Record last verified: 2012-07

Locations

US (5)