Adenosine Dual Source Computed Tomography (CT) Versus Adenosine Single Photon Emission Computed Tomography (SPECT) - Full Text View

Sponsors and Collaborators:	Cedars-Sinai Medical Center Astellas Pharma US, Inc.
Information provided by:	Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00892307

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

MedlinePlus related topics: Anatomy CT Scans Coronary Artery Disease

Drug Information available for: Adenosine

U.S. FDA Resources

Study Type:

Observational

Study Design:

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

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 ]

Estimated Enrollment:	20
Study Start Date:	February 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Somatom Definition Dual Source CT Scanner Stress/Rest Image scan using weight based CT contrast dye

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

Contacts

Contact: Balaji Tamarappoo, MD

310 423-3095

tamarappoob@cshs.org

Locations

United States, California
Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Daniel S Berman, MD

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:	Cedars Sinai Medical Center ( Daniel S. Berman, MD )
Study ID Numbers:	IRB # 10928/11143
Study First Received:	April 24, 2009
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00892307 History of Changes
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

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Vasodilator Agents
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Agents
Ischemia

Arteriosclerosis
Coronary Disease
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Adenosine
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Vasodilator Agents
Heart Diseases
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Arteriosclerosis
Pharmacologic Actions
Coronary Disease

Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Adenosine
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009