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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Daniel S. Berman, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00892307
First received: April 24, 2009
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: February 2007
Study Completion Date: May 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Coronary Artery Disease

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892307

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

No publications provided

Responsible Party: Daniel S. Berman, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00892307     History of Changes
Other Study ID Numbers: IRB # 10928/11143
Study First Received: April 24, 2009
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Diagnostic Imaging
Dual Source Multidetector Computed Tomography
Computed Tomography
CT
Single Photon Emission Computed Tomography
SPECT
Myocardial Perfusion
Atherosclerosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 15, 2014