A data base of clinical studies is required for quality assurance of software used for analysis of radionuclide cardiac imaging procedures. Studies used must be rigorously validated in terms of both the clinical condition of the patient undergoing the procedure and the imaging protocol used. Selection protocols for the creation of a software phantom data base of normal studies and three typical patterns of cardiac disease--recent transmural myocardial infarction, isolated myocardial ischaemia and dilated cardiomyopathy--have been developed by the Cardiac Working Group of the European COST B2 project in association with the Cardiac Task Group of the European Association of Nuclear Medicine and the Working Group on Nuclear Cardiology of the European Society of Cardiology. These protocols include criteria for the interpretation of qualitative and quantitative non-radionuclide data. Compliance of the clinical data with the selection criteria will have to pass scrutiny by an international team for each study used as a software phantom. The radionuclide studies encompass stress and rest myocardial perfusion studies (planar and single photon emission tomography) using thallium-201 and technetium-99m methoxyisobutylisonitrile and rest gated blood pool studies. Methods for acquisition of data are defined for each type of study and for each individual study a portfolio of all clinical data is established. A pilot study is required to investigate the problems and logistics of distributing clinical radionuclide studies between a range of computers and institutes, and to ascertain the procedures necessary for analytical comparison of the results obtained.

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