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BBG 012

BBG 012. Study Procedures. Rotterdam 23. January 2002. Refer to CRF-Pages. 0 2. Patient Inclusion (1). Enrol from cath lab: biplane and calibrated cineangiocardiography no atrial fibrillation no preceeding ES. Refer to CRF-Pages. 0 2. Patient Inclusion (2). Age  18 years

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BBG 012

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  1. BBG 012 Study Procedures Rotterdam 23. January 2002

  2. Refer to CRF-Pages 0 2 Patient Inclusion (1) Enrol from cath lab: • biplane and calibrated cineangiocardiography • no atrial fibrillation • no preceeding ES

  3. Refer to CRF-Pages 0 2 Patient Inclusion (2) • Age  18 years • Informed Consent • Indicated for LV-Function Assessment •  2 Segments with impaired EBD

  4. Refer to CRF-Pages 0 4 Patient Inclusion (3) Stratify to 3 different EF-Groups (based on onsite EF from cineangiocardiography)> 55 %35- 54 %< 35 %enrol 5 patient in each EF-Category

  5. Refer to CRF-Pages 0 2 Patient Inclusion (3) Perform Study Echocardiography within 24 h to Cineangiocardiography Perform Cardiac MRI within 24 h before or 48 h post Study Echocardiography

  6. Refer to CRF-Pages 0 5 0 9 Procedures before study echocardiography • within 24 hours: Patient Information / Informed Consent Patient History, Concomitant Medications • within 2 hours: Physical Examination Vital Signs 12 Lead ECG

  7. UNENHANCED - LOOP 1-8 Refer to CRF-Pages 1 0 PreSet BBG 012 Native M-Mode meaurements (parasternal SAX or LAX) a 4 CV 1 5 cycles DIGITAL a 2 CV 2 5 cycles DIGITAL 5 cycles a 3 CV 3 DIGITAL 5 cycles SAX 4 DIGITAL AQ – a4CV 5 CK a 4 CV 5 cycles DIGITAL 6 5 cycles a 2 CV CK DIGITAL 5 cycles 7 a 3 CV CK DIGITAL 5 cycles 8 SAX CK DIGITAL DIGITAL • Start SonoVue Infusion at 1 ml per minute • Use PreSet – BBG 012 – LVO – • Adjust Infusion Rate • If necessary administer additional Bolus • (up to 2 ml single volume, up to 5 ml total volume Manual Infusion Pump

  8. Refer to CRF-Pages 1 1 PreSet BBG 012 SonoVue Start SonoVue Infusion (at 1 ml / min) SonoVue - LOOP 9-16 a 4 CV 9 5 cycles DIGITAL a 2 CV 10 5 cycles DIGITAL 5 cycles a 3 CV 11 DIGITAL 5 cycles SAX 12 DIGITAL AQ – a4CV 13 CK a 4 CV 5 cycles DIGITAL 14 5 cycles a 2 CV CK DIGITAL 5 cycles 15 a 3 CV CK DIGITAL 5 cycles 16 SAX CK DIGITAL DIGITAL • Start SonoVue Infusion at 1 ml per minute • Use PreSet – BBG 012 – LVO – • Adjust Infusion Rate • If necessary administer additional Bolus • (up to 2 ml single volume, up to 5 ml total volume Manual Infusion Pump

  9. Refer to CRF-Pages 1 2 PreSet TCE 3 Continue with SonoVue Infusion (at optimal Infusion Rate) MCE – Real Time Perfusion 2 flash replenishment cycles SVHS a 4 CV SVHS a 2 CV SVHS a 3 CV Offline Assesssment of EF, LV-Function, EBD, Wall Motion Assessment, Myocardial Perfusion Grading DIGITAL • Start SonoVue Infusion at 1 ml per minute • Use PreSet – BBG 012 – LVO – • Adjust Infusion Rate • If necessary administer additional Bolus • (up to 2 ml single volume, up to 5 ml total volume Manual Infusion Pump

  10. Post Study Examinations Refer to CRF-Pages 1 3 1 4 Procedures after Study Echocardiography • within 2 hours: Physical Examination Vital Signs 12 Lead ECG

  11. Onsite Image Quality, Contrast Quality and EBD EF and LV-Volumes: visual (only EF), Simpsons method and aGSF Regional Wall Motion Analysis: Visual (aRSF supportive) M-Mode-Measurement for Left Chamber Perfusion Assessment Offsite Quality Control (E 1) Image Quality, Contrast Quality and EBD EF and LV-Volumes: visual (only EF), Simpsons method and aGSF Visual Regional Wall Motion Analysis (aRSF supportive) Efficacy-Evaluations Echocardiography

  12. Grading Scale for Myocardial Perfusion Category Grade Description Diagnostic Normal Perfusion N Rate of contrast filling is adequate and contrast uniformly fills the area (segment or region) Abnormal Perfusion X Perfusion defectArea shows an absence of contrast, regardless of the rate of contrast filling S Delayed perfusionRate of contrast filling is slow, but contrast uniformly fills the area I Reduced perfusionRate of contrast filling is adequate, but contrast filling is incomplete or patchy IS Reduced and delayed perfusionRate of contrast filling is slow and contrast filling is incomplete or patchy Nondiagnostic AF Imaging artifact AT Contrast attenuation NV Segment not visualized IA Indeterminate assessment

  13. Cineangiocardiography Refer to CRF-Pages 2 2 2 4 LV-Volumes and EF WMA Segmental Evaluation

  14. Onsite EF and LV-Volumes based on area-length or Simpsons method Visual Regional Wall Motion Analysis Assessement of CAD (15 Segment Model) Offsite Quality Control (CA 1) EF and LV-Volumes based on Simpsons method Visual Regional Wall Motion Analysis(automatic methods supportive) Efficacy-Evaluations Cine Angiocardiography

  15. Cardiac MRI Refer to CRF-Pages 2 6 LV-Volumes and EF WMA Segmental Evaluation

  16. Onsite EF and LV-Volumes: based on tracking of subsequent short axis Visual Regional Wall Motion Analysis(Tagging supportive) Offsite EF and LV-Volumes: based on tracking of subsequent short axis Visual Regional Wall Motion Analysis(Tagging supportive) Efficacy-Evaluations Cardiac-MRI

  17. Data Transfer • Initialised and Labeled MOD from BBG • SVHS Videotapes • Courier Service for transmission of MODs (Echo) and CDs (Cineangio + MRI) from Centre to Medidata • Transfer of CDs from Medidata to Offsite Readers

  18. External Quality Control Quality Criteria • Complete and transparent Digital Storage of Required Loops • Correct Scanplanes • Machine Settings • Avoidable Artefacts Rotterdam 23. January 2002

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