CClinicalTrials.gg
Status unknownNCT00864591Updated Mar 18, 2009

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

An observational study in Coronary Artery Disease and Cardiac Perfusion, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-03-18.

Sponsored by Sheba Medical Center · Observational

The sponsor has not verified this record recently (last verified Mar 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease
  • Cardiac Perfusion

Keywords

  • SPECT Imaging
  • Stress adenosine CMR
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 50 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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.

Inclusion criteria

  • Suspected ischemia referred to SPECT stress imaging

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)

Groups and 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.

    Procedure: SPECT Imaging · Procedure: Stress Adenosine CMR

Interventions

  • ProcedureSPECT 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.

  • ProcedureStress 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.

06

What researchers measure

Primary outcomes

  1. Stress adenosine cardiac MRIis not inferior to SPECT imaging in diagnosing myocardial ischemia

    Time frame: 1 year

07

Study locations

1 site
  • Chaim Sheba Medical Center
    Tel hashomer, 52621, Israel
    • Orly Goitein, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00864591
Lead sponsor
Sheba Medical Center
First posted
Mar 18, 2009
Start date
Apr 2009
Primary completion
Apr 2010 (estimated)
Completion
Oct 2010 (estimated)
Last update
Mar 18, 2009

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion