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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00864591
First received: March 4, 2009
Last updated: March 17, 2009
Last verified: March 2009

March 4, 2009
March 17, 2009
April 2009
April 2010   (final data collection date for primary outcome measure)
Stress adenosine cardiac MRIis not inferior to SPECT imaging in diagnosing myocardial ischemia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00864591 on ClinicalTrials.gov Archive Site
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Stress Adenosine Cardiac Magnetic Resonance (MR) Comparison With Single Photon Emission Computed Tomography (SPECT) Imaging
Stress Adenosine Cardiac MR Comparison With SPECT Imaging

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Coronary Artery Disease
  • Cardiac Perfusion
  • 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.

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
October 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Orly Goitein, MD +972 3 5302530 orly.goitein@sheba.health.gov.il
Israel
 
NCT00864591
SHEBA-08-5654-OG-CTIL
No
Orly Goitein MD, Sheba Medical Center
Sheba Medical Center
Not Provided
Not Provided
Sheba Medical Center
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP