Cardium Announces Cedars-Sinai Heart Institute as the SPECT Imaging Core Lab for the Recently Announced GenerxÃ‚® Phase 3 Clinical Registration Study in the Russian Federation
SAN DIEGO, June 22, 2011 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced the selection of the Cedars-Sinai Medical Center Nuclear Cardiology Core Laboratory (Cedars-Sinai Core Laboratory), Los Angeles, California, to serve as the central core lab for the Company’s Generx ASPIRE clinical study. Cedars-Sinai Core Laboratory will be responsible for the consolidation and analysis of SPECT (single-photon emission computed tomography) myocardial imaging data from the Russian medical centers participating in the Generx® Phase 3 ASPIRE registration study that recently received clearance for initiation from the Russian Ministry of Health and Social Development. SPECT is a common imaging technique that is used throughout the world to quantitatively assess myocardial ischemia in patients with coronary artery disease. The ASPIRE study’s primary endpoint will be improvement in perfusion (blood flow) defect size as measured by SPECT imaging.
Cedars-Sinai Medical Center Nuclear Cardiology Core Laboratory is considered one of the world’s leading core laboratories for SPECT imaging. It has operated as an independent core laboratory for over 20 years and has participated in numerous multi-center clinical trials, including the recent COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) clinical study enrolling over 3,200 patients at over 60 clinical study sites. The scope of work performed by the Cedars-Sinai Core Laboratory includes imaging protocol design, quality assurance and control, interpretation, and da