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Adenosine Dual Source Computed Tomography (CT) Versus Adenosine Single Photon Emission Computed Tomography (SPECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00892307
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : November 13, 2013
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Daniel S. Berman, Cedars-Sinai Medical Center

Brief Summary:
Researchers hope that this new non-invasive multi-detector scanner (DSCT) will provide diagnostic information comparable to the combination of traditional SPECT (for function and blood flow) and CT imaging (for a precise anatomical view).

Condition or disease Intervention/treatment
Coronary Artery Disease Radiation: Dual Source Multidetector CT (DSCT) w/ Adenosine enhancement

Detailed Description:

The DSCT scanner is able to assess cardiac blood flow (myocardial perfusion) at the same time as coronary anatomy. The results derived from these scans will be compared to standard SPECT imaging.

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

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Study Type : Observational
Actual Enrollment : 34 participants
Time Perspective: Prospective
Official Title: Coronary Anatomy and Physiology Using Multidetector Dual Source Computed Tomography With Adenosine Enhancement: Comparative Study With SPECT Imaging: Pilot Studies I/II
Study Start Date : February 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
Drug Information available for: Adenosine

Intervention Details:
  • Radiation: 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 Names:
    • Dual Source Multidetector Computed Tomography
    • Dual Source CT
    • Dual Source CT with adenosine enhancement
    • Adenosine enhanced CT
    • Siemens Somatom Definition Dual Source Scanner

Primary Outcome Measures :
  1. To show that adenosine enhanced DSCT will enhance regular Multidetector Spiral Computed Tomography (MSCT) "diagnostic power" to detect significant (e.g., > 50%) coronary stenosis [ Time Frame: One day ]

Secondary Outcome Measures :
  1. To assess coronary anatomical results obtained by CT Angiography (CTA) at high heart rates in terms of the rate of assessable coronary segments. [ Time Frame: One day ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Coronary Artery Disease

Pilot 1:

Inclusion Criteria:

  • Provide written consent and are willing to comply with protocol requirements
  • Are at least 18 years of age
  • Are referred for clinically-ordered SPECT
  • Have known CAD

Exclusion Criteria:

  • Patients being referred to invasive coronary angiography will not be included in this pilot
  • 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:

Inclusion Criteria:

  • Have had prior (within 30 days) positive Adeno-SPECT scan

Exclusion Criteria:

  • Patients with contraindications to coronary angiography

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00892307

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Astellas Pharma US, Inc.
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Principal Investigator: Daniel S Berman, MD Cedars-Sinai Medical Center

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Responsible Party: Daniel S. Berman, Principal Investigator, Cedars-Sinai Medical Center Identifier: NCT00892307     History of Changes
Other Study ID Numbers: IRB # 10928/11143
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Keywords provided by Daniel S. Berman, Cedars-Sinai Medical Center:
Diagnostic Imaging
Dual Source Multidetector Computed Tomography
Computed Tomography
Single Photon Emission Computed Tomography
Myocardial Perfusion
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action