Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
|ClinicalTrials.gov Identifier: NCT01949844|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2013
Last Update Posted : July 26, 2017
This is a pilot study in a patient population with suspected Coronary Artery Disease CAD) as defined by the presence of an abnormal nuclear (PET/SPECT) perfusion scan. In this study design, PET/SPECT will serve as the comparative standard for presence of myocardial ischemia. We intend to determine the accuracy of a novel MR technique for localization of perfusion deficits in comparison to PET/SPECT.
This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic accuracy of the cardiac MRI procedure as a whole
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease CAD||Drug: regadenoson Drug: Optimark® Device: Myocardial perfusion MRI||Not Applicable|
A total of 2 imaging protocols will be used in this study: (1) One-day SPECT protocol, which involves the subjects undergoing stress myocardial perfusion SPECT and MRI in the same day; (2) Two-day PET/SPECT protocol, which involves MRI of subjects who have had a recent abnormal PET/SPECT study and includes an optional second-day visit.
Two blinded readers will interpret MR and SPECT/PET studies by consensus to assess the presence of perfusion deficits at stress and rest.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Artifact-Free High-resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Suspected or known CAD
Myocardial Perfusion MRI with administration of gadolinium contrast(Optimark®)and vasodilator(regadenoson used off-label)
Lexiscan® is being used off-label. The FDA Issued IND # is 119898. For the cardiac MRI, Lexiscan® will be used at the same dosage and administration as prescribed in the package insert - 5 mL (0.4 mg regadenoson) as packaged and supplied by the manufacturer, Astellas Pharma U.S., in single-use pre-filled syringes administered by rapid intravenous injection, followed immediately by saline flush.
Other Name: Lexiscan®Drug: Optimark®
For the cardiac MR, the contrast agent, Optimark® is administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual injection.
Other Names:Device: Myocardial perfusion MRI
- Presence and severity of perfusion deficit on images [ Time Frame: baseline only ]Presence and severity of myocardial perfusion deficit on MR and PET/SPECT scans as assessed by blinded readers on a 4-point scale from none to severe.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949844
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Daniel S Berman, MD||Cedars-Sinai Medical Center|