Adenosine Dual Source Computed Tomography (CT) Versus Adenosine Single Photon Emission Computed Tomography (SPECT)
NCT ID: NCT00892307
Last Updated: 2013-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2007-02-28
2011-05-31
Brief Summary
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Detailed Description
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To further evaluate obstruction in the coronary arteries, physicians may refer for an invasive Coronary Angiogram, the current gold standard for diagnosis of Coronary Artery Disease (CAD). By validating the DSCT scanner as a system with which to assess the extent of obstruction in the coronary arteries, physicians may be able to lessen the occurrence of an invasive exam.
Procedures: Each pilot anticipates enrolling 20 subjects.
Pilot 1: Clinical Follow-up Rest/Stress Adeno-SPECT and Research Stress /Rest Adeno-DSCT obtained in the same patient during the same period of stress testing
* Radiation: Thallium injection for rest SPECT
* Drug: Single dose Adenosine Infusion for DSCT and SPECT
* Radiation: Sestamibi injection for stress SPECT
* Drug: CT contrast
* Radiation: Stress DSCT /Rest DSCT
Pilot 2: Research Stress/ Rest Adeno-DSCT obtained within 30 days of initial positive SPECT finding
* Drug: Adenosine Infusion for DSCT
* Drug: CT contrast
* Radiation: Stress DSCT /Rest DSCT
Both pilot studies will relate results to subject history, ECG and cardiac angiogram, if available
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Interventions
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Dual Source Multidetector CT (DSCT) w/ Adenosine enhancement
Somatom Definition Dual Source CT Scanner Stress/Rest Image scan using weight based CT contrast dye
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are at least 18 years of age
* Are referred for clinically-ordered SPECT
* Have known CAD
* Have had prior (within 30 days) positive Adeno-SPECT scan
Exclusion Criteria
* Caffeine intake within the 24 hours prior to adenosine stress testing
* Pregnancy (known or suspected)
* Intolerance or contraindication to adenosine (severe Asthma…)
* Intake of methylxanthine containing medications such as theophylline that have not been withdrawn and would interfere with the effectiveness of adenosine.
* Unstable coronary syndromes
* Uncontrolled congestive cardiac failure or cardiogenic shock
* Uncontrolled hypertension with resting BP \> 200/110
* More than 30 days between the Adeno-SPECT and the Adeno-DSCT
* Revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery) between the Adeno-SPECT and the Adeno-DSCT
* Change in clinical status as determined by the investigator
* Inability to be on same medication regime 24 hrs prior to Adeno-SPECT and Adeno DSCT
* Patients with chronic renal failure (C.C.T. \< 60 ml/m2/sec)
* Patients with allergy to contrast iodinated media
* Congestive heart failure
* History of thromboembolic disorders
* Multiple myeloma
* Hyperthyroidism
* Pheochromocytoma
* Atrial fibrillation
* Inability to perform breath hold for 12 seconds
Pilot 2:
All inclusions/exclusions are the same as Pilot 1, WITH THE ADDITION OF:
* Patients with contraindications to coronary angiography
18 Years
ALL
No
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Daniel S. Berman
Principal Investigator
Principal Investigators
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Daniel S Berman, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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Other Identifiers
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IRB # 10928/11143
Identifier Type: -
Identifier Source: org_study_id