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Trial record 21 of 1178 for:    adenosine

Stress Adenosine Cardiac Magnetic Resonance (MR) Comparison With Single Photon Emission Computed Tomography (SPECT) Imaging

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ClinicalTrials.gov Identifier: NCT00864591
Recruitment Status : Unknown
Verified March 2009 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 18, 2009
Last Update Posted : March 18, 2009
Sponsor:
Information provided by:
Sheba Medical Center

Tracking Information
First Submitted Date March 4, 2009
First Posted Date March 18, 2009
Last Update Posted Date March 18, 2009
Study Start Date April 2009
Estimated Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2009)
Stress adenosine cardiac MRIis not inferior to SPECT imaging in diagnosing myocardial ischemia [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stress Adenosine Cardiac Magnetic Resonance (MR) Comparison With Single Photon Emission Computed Tomography (SPECT) Imaging
Official Title Stress Adenosine Cardiac MR Comparison With SPECT Imaging
Brief Summary

This study is designed to determine the diagnostic value of adenosine cardiac magnetic resonance (CMR) when compared with SPECT.

The investigators hypothesized that adenosine CMR could detect ischemia and is not inferior to SPECT imaging. In addition stress adenosine cardiac MRI offers a "one stop shop" enabling evaluation of cardiac function, rest and stress perfusion and viability.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

patients undergoing SPECT stress imaging, for the evaluation of myocardial ischemia.

The study group will include patients with either normal undergoing SPECT stress imaging or with mild to severe ischemia, to include the entire spectrum of coronary artery disease.

Patients will be pre selected and evaluated by a non-dependent cardiologist in order to verify that patients in whom the repeat stress might pose a serious risk will be excluded from the study.

Condition
  • Coronary Artery Disease
  • Cardiac Perfusion
Intervention
  • Procedure: SPECT Imaging
    Myocardial SPECT imaging will be performed 10-12 minutes after the stress injection of Tl-201, at 4 hours, and at 18-24 hours in patients with non-reversible or partially reversible defect on 4-hour imaging. Images will be obtained with a rotating single- or dual-head gamma camera equipped with low-energy high resolution collimators. Energy windows of 20% and 10% will be centered on the 70 KeV and 167 KeV peaks of Tl-201, respectively. Thirty images will be obtained (40 seconds each for the stress and 4-hour redistribution imaging, and 60 seconds each for the 18-24-hour imaging) over 180° extending from the 45° right anterior oblique to the 45° left posterior oblique projections.Localization of the disease in the left anterior descending artery (LAD), left circumflex (Cx) and right coronary artery (RCA) will be performed using a quantitative analysis software.
  • Procedure: Stress Adenosine CMR

    CMR will be performed using a 3-T scanner and a dedicated eight-element cardiac phased-array coil Cine CMR will be performed using steady state free precession in the short-axis, two chamber, three chamber and four-chamber, 8 mm thick, separated by 0-mm gaps.

    Adenosine perfusion CMR: Adenosine will be administered intravenously at 140 µg/kg/min over 6 min. Four minutes into the infusion (or earlier if angina is provoked), a bolus (0.1 mmol/kg at 5 ml/s) of Gadolinium DTPA will be administered. Patients will be instructed to hold their breath. Stress perfusion images will be acquired in the short axis plane (parameters and planning will be similar for stress and rest perfusion evaluation). The patients will be monitored by vector ECG, noninvasive sphygmomanometry, pulse oximetry and capnography.

Study Groups/Cohorts SPECT and stress CMR patients

patients undergoing SPECT stress imaging, for the evaluation of myocardial ischemia.

The study group will include patients with either normal undergoing SPECT stress imaging or with mild to severe ischemia, to include the entire spectrum of coronary artery disease.

Patients will be pre selected and evaluated by a non-dependent cardiologist in order to verify that patients in whom the repeat stress might pose a serious risk will be excluded from the study.

Interventions:
  • Procedure: SPECT Imaging
  • Procedure: Stress Adenosine CMR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 17, 2009)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2010
Estimated Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Suspected ischemia referred to SPECT stress imaging

Exclusion Criteria:

  • Standard contraindications to MRI including (pacemaker/defibrillator, metallic clips on brain aneurysms, metal fragment in the eye, etc...)
  • Congestive heart failure.
  • Hemodynamic instability.
  • History of asthma or bronchospastic disease.
  • Arrhythmia
  • Creatinine >1.4
  • Non compliant patient, not able to lie supine in the MRI scanner for 1 hour.
  • Pregnant patients
  • Patients for whom the repeat stress might pose a significant risk.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00864591
Other Study ID Numbers SHEBA-08-5654-OG-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Orly Goitein MD, Sheba Medical Center
Study Sponsor Sheba Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Sheba Medical Center
Verification Date March 2009