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

NCT ID: NCT00864591

Last Updated: 2009-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-10-31

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.

Conditions

Coronary Artery Disease; Cardiac Perfusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

SPECT Imaging

Intervention Type: PROCEDURE

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.

Stress Adenosine CMR

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sheba Medical Center

Locations

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

Central Contacts

Orly Goitein, MD

Role: CONTACT

orly.goitein@sheba.health.gov.il

+972 3 5302530

Other Identifiers

SHEBA-08-5654-OG-CTIL

Identifier Type: -

Identifier Source: org_study_id