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

Sponsor

Hartford Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01179230

Collaborator

Bracco Diagnostics, Inc (Industry)

136

Enrollment

Locations

Duration (Months)

27.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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	Phase
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 :

Jan 1, 2005

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	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

Arm

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

Coronary Artery Disease [30 days]

Secondary Outcome Measures

Myocardial Ischemia [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	The Heart Center, PC	Huntsville	Alabama	United States	35801
2	Hartford Hospital	Hartford	Connecticut	United States	06102-5037
3	Cardiovascular Imaging Technologies, LLC	Kansas City	Missouri	United States	64111
4	Sanford Health Clinical Research	Fargo	North Dakota	United States	58122-0011
5	Ohio Health Research Institute	Columbus	Ohio	United States	43214