Facility

KCRI office is responsible for receipt, filing and tracking of the angiographic materials sent for analysis.
Complete infrastructure of the analytical laboratory is housed in KCRI premises.

The infrastructure of the analytical laboratory includes the following minimum hardware:

  • analytical workstations with double monitors, dedicated to management of database and quantitative analysis

  • secondary workstations for reviewing the angiograms, compiling the data and generating the study documents other than analysis reports

  • high capacity network printer serving all workstations

  • data storage server

  • locked shelved system for archiving the past and ongoing studies

  • locked cabinets for restricted access materials

The analytical laboratory utilizes the FDA-approved software enabling the following analytic procedures:

  • a DICOM medical image viewer for review of images and epicardial flow analysis

  • a quantitative angiographic program

  • an IVUS-Virtual Histology program

  • a quantitative program for measuring angiographic volumes of the left ventricle

  • a quantitative program for measuring microvascular perfusion in the heart by assessing the intensity of contrasting (myocardial blush)

  • investigative angio 3D reconstruction protocols

The above programs are built into the system software suite, which integrates all analytical components with a program to create and manage the patient record of demographic information, coronary anatomy, qualitative lesion analysis and the reports from single or multiple quantitative analyses preformed in any of the above analytical programs. Furthermore, the software suite, exports the compiled data to the database for further data processing and analysis according to the HIPAA standards.

The Laboratory Manual and the Standard Operating Procedures are available for Sponsor audit on site, pending exchange of confidentiality disclosure agreement between KCRI and the Sponsor.