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BBG 012
Study Procedures
Rotterdam 23. January 2002
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• Informed Consent• Indicated for LV-Function
Assessment
2 Segments with impaired EBD
Refer to CRF-Pages 0 2
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
Refer to CRF-Pages 0 4
Patient Inclusion (3)
Perform Study Echocardiography within 24 h to Cineangiocardiography
Perform Cardiac MRI within 24 h before or 48 h post Study Echocardiography
Refer to CRF-Pages 0 2
• within 24 hours: Patient Information / Informed Consent
Patient History, Concomitant
Medications
• within 2 hours: Physical Examination Vital Signs
12 Lead ECG
Procedures before study echocardiography
Refer to CRF-Pages 0 5 0 9
M-Mode meaurements (parasternal SAX or LAX)
a 4 CV
a 2 CV
a 3 CV
SAX
5 cycles
5 cycles
5 cycles
5 cycles
1DIGITAL
2DIGITAL
3DIGITAL
4DIGITAL
Pre
Set B
BG
012 N
ativ
e
AQ – a4CV
5 cycles
5 cycles
5 cycles
5 cycles
5DIGITAL
6DIGITAL
7DIGITAL
8
a 4 CV
a 2 CV
a 3 CV
SAXCK DIGITAL
CK
CK
CK
Refer to CRF-Pages UNENHANCED - LOOP 1-81 0
Start SonoVue Infusion (at 1 ml / min)
a 4 CV
a 2 CV
a 3 CV
SAX
5 cycles
5 cycles
5 cycles
5 cycles
9DIGITAL
10DIGITAL
11DIGITAL
12DIGITAL
AQ – a4CV
5 cycles
5 cycles
5 cycles
5 cycles
13DIGITAL
14DIGITAL
15DIGITAL
16
a 4 CV
a 2 CV
a 3 CV
SAXCK DIGITAL
CK
CK
CK
Pre
Set B
BG
012 S
on
oV
ue
Refer to CRF-Pages 1 1 SonoVue - LOOP 9-16
Continue with SonoVue Infusion (at optimal Infusion Rate)
a 4 CV
a 2 CV
a 3 CV
2 flash replenishment cyclesSVHS
Pre
Set T
CE 3
Refer to CRF-Pages 1 2 MCE – Real Time Perfusion
SVHS
SVHS
Offline Assesssment of EF, LV-Function, EBD, Wall Motion Assessment,
Myocardial Perfusion Grading
• within 2 hours: Physical Examination Vital Signs
12 Lead ECG
Procedures after Study Echocardiography
Refer to CRF-Pages 1 3 Post Study Examinations1 4
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
Grading Scale for Myocardial Perfusion
CategoryGrad
eDescription
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
IReduced perfusionRate of contrast filling is adequate, but contrast filling is incomplete or patchy
ISReduced 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
LV-Volumes and EF
WMA Segmental Evaluation
Refer to CRF-Pages 2 2 Cineangiocardiography2 4
Efficacy-Evaluations Cine Angiocardiography
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)
LV-Volumes and EF
WMA
Segmental Evaluation
Refer to CRF-Pages 2 6 Cardiac MRI
Efficacy-Evaluations Cardiac-MRI
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)
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
External Quality Control
Rotterdam 23. January 2002
Quality Criteria
• Complete and transparent Digital Storage of Required Loops
• Correct Scanplanes• Machine Settings• Avoidable Artefacts
