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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

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.


Condition or disease Intervention/treatment
Coronary Artery Disease Cardiac Perfusion Procedure: SPECT Imaging Procedure: Stress Adenosine CMR

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress Adenosine Cardiac MR Comparison With SPECT Imaging
Study Start Date : April 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Stress adenosine cardiac MRIis not inferior to SPECT imaging in diagnosing myocardial ischemia [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864591


Contacts
Contact: Orly Goitein, MD +972 3 5302530 orly.goitein@sheba.health.gov.il

Locations
Israel
Chaim Sheba Medical Center Not yet recruiting
Tel hashomer, Israel, 52621
Principal Investigator: Orly Goitein, MD         
Sponsors and Collaborators
Sheba Medical Center

Responsible Party: Orly Goitein MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00864591     History of Changes
Other Study ID Numbers: SHEBA-08-5654-OG-CTIL
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: March 18, 2009
Last Verified: March 2009

Keywords provided by Sheba Medical Center:
SPECT Imaging
Stress adenosine CMR

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
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action