Detecting Heart Disease Using First Pass Imaging With Gated SPECT Perfusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To determine if stress first pass imaging in conjunction with gated SPECT, with or with out low level exercise,will improve the sensitivity for detecting ischemic heart disease
Study Overview
Brief Summary
The aim of this study is to determine if stress first pass imaging in conjunction with a nuclear scan will improve the sensitivity for detecting heart disease. This study will also test the usefulness of a nuclear medicine camera, CDLCAM One Pass Angiography system.
Detailed Description
In this clinical trial, patients with suspected or previously diagnosed coronary artery disease who are clinically referred for either a treadmill exercise stress/rest SPECT study or a vasodilatation stress/rest SPECT study will be considered for this protocol. The vasodilation study may be either adenosine or regadenosin. In addition to the stress study, a stress/rest echocardiography study and first pass image will also be obtained. The reason to include echocardiography is to provide an independent measurement of the ejection fraction during pharmacological stress for comparison to the ejection fraction from the first pass study and from the ECG-gated SPECT study performed at rest. This will evaluate the added value of calculation of stress left ventricular ejection fraction (LVEF) over gated SPECT resting EF. This information will also assist in evaluating LV dysfunction following induction of pharmacological stress Nuclear imaging compared with echocardiographic stress EF, established imaging modalities for assessment of coronary heart disease.
The study will include two ECHO imaging sessions and two SPECT imaging sessions.
Patients will undergo a resting first pass image during the administration 99mTc-tetrofosmin; and a resting ECHO study at an appropriate imaging time. The resting ECHO will also be used to assess patient imaging window quality and to optimize equipment settings for subsequent stress images. A rest gated-SPECT image will be acquired at the appropriate imaging time.
The patient will then undergo a standard vasodilation stress infusion. A first pass image will be obtained during the administration of 99mTc-tetrofosmin. An ECHO will be obtained prior to the completion of the infusion. A gated-SPECT study will then be performed at the appropriate imaging time.
Tetrofosmin ECG-gated SPECT Imaging:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patient consumed food/beverage/medication containing caffeine/methylxanthines up to 12 hours prior to infusion
- •Exacerbation of COPD, Asthma (actively wheezing)
- •Sinus node dysfunction in absence of pacemaker
- •Use of Aggrenox (ASA/Dipyridamole), Pentoxifylline (Trental) , or oral Dipyridamole (Persantine)
- •Atrial fibrillation
- •Pregnant/breast feeding
- •Non English speaking patients
- •Subject is allergic or intolerant to aminophylline, regadenoson
- •Subject has a history of known or suspected bronchospastic lung disease [e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD, etc.)]
- •Patients with first degree or second degree AV block
Outcomes
Primary Outcomes
To determine if stress first pass imaging in conjunction with gated SPECT, with or with out low level exercise,will improve the sensitivity for detecting ischemic heart disease
Time Frame: First pass imaging done in conjunction with SPECT study
First pass imaging will be done in conjunction with the clinically indicated SPECT study.
Secondary Outcomes
- To determine if first pass imaging provides a more reproducible approach for evaluation of both rest and stress global LV function over gated SPECT perfusion imaging compared with 3D echocardiography(Immediately following administration of regadenoson.)