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
  Purpose

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 Intervention
Coronary Artery Disease
Cardiac Perfusion
Procedure: SPECT Imaging
Procedure: Stress Adenosine CMR

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress Adenosine Cardiac MR Comparison With SPECT Imaging

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Stress adenosine cardiac MRIis not inferior to SPECT imaging in diagnosing myocardial ischemia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Orly Goitein MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00864591     History of Changes
Other Study ID Numbers: SHEBA-08-5654-OG-CTIL
Study First Received: March 4, 2009
Last Updated: March 17, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 17, 2014