Stress Adenosine Cardiac Magnetic Resonance (MR) Comparison With Single Photon Emission Computed Tomography (SPECT) Imaging
Recruitment status was Not yet recruiting
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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 |
- 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 |
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:
- 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| Contact: Orly Goitein, MD | +972 3 5302530 | orly.goitein@sheba.health.gov.il |
| Israel | |
| Chaim Sheba Medical Center | Not yet recruiting |
| Tel hashomer, Israel, 52621 | |
| Principal Investigator: Orly Goitein, MD | |
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 June 18, 2013