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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00864591
Enrollment
50
Registered
2009-03-18
Start date
2009-04-30
Completion date
2010-10-31
Last updated
2009-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Perfusion, Coronary Artery Disease

Keywords

SPECT Imaging, Stress adenosine CMR

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.

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.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Stress adenosine cardiac MRIis not inferior to SPECT imaging in diagnosing myocardial ischemia1 year

Countries

Israel

Contacts

Primary ContactOrly Goitein, MD
orly.goitein@sheba.health.gov.il+972 3 5302530

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026