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

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ClinicalTrials.gov Identifier: NCT00892307
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : November 13, 2013
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Daniel S. Berman, Cedars-Sinai Medical Center

April 24, 2009
May 4, 2009
November 13, 2013
February 2007
February 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00892307 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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Not Provided
 
Adenosine Dual Source Computed Tomography (CT) Versus Adenosine Single Photon Emission Computed Tomography (SPECT)
Coronary Anatomy and Physiology Using Multidetector Dual Source Computed Tomography With Adenosine Enhancement: Comparative Study With SPECT Imaging: Pilot Studies I/II
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).

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

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Coronary Artery Disease
Coronary Artery Disease
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
20
May 2011
February 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00892307
IRB # 10928/11143
No
Not Provided
Not Provided
Daniel S. Berman, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Astellas Pharma US, Inc.
Principal Investigator: Daniel S Berman, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
November 2013