myCSG © |Area: SDTM| Concept: CV : Cardiovascular System Findings | Lesson: L101 : Cardiovascular System Findings - Echocardiogram Results |

 

Background
  • In some clinical trials, we may have to collect data about physiological and morphological findings related to cardiovascular system, including the heart, blood vessels and lymphatic vessels.
  • Some example data points are:
    • Blood flow rate
    • Cardiac output
    • Left Ventricular Ejection Fraction
    • Peak Blood Flow Velocity
  • SDTM standard has a standard domain for capturing these findings - "Cardiovascular System Findings (CV)"
  • CV dataset belongs to Findings class and has an expected record structure of 'One record per finding or result per time point per visit per subject'

An Overview of the Cardiovascular System Components

What type of information is typically collected or presented?
  • Date of assessment
  • Test performed status
    • Yes
    • No 
      • Reason not performed
  • Short name of the test
  • Name of the test
  • Result
    • in original units
    • in standard units
  • Derived information
    • Baseline flag - when results of a test are collected over pre and post treatment period
 
Cardiovascular System Findings, Example showing one record where none of the tests are performed, EXample showing one record where only some of the tests were performed

Lesson description will be added soon

ECHO : Echocardiogram
Question Response
Assessment Performed?
[ECHO_YN]

No
Yes
If Yes, date performed
[ECHODAT]
Left ventricular ejection fraction (LVEF) (%)
[LVEF]
Estimated Right ventricular ejection fraction (RVEF) (%)
[RVEF]



VARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_ECHO
STUDYID Study Identifier Char Set to 'statschoice'
DOMAIN Domain Abbreviation Char Set to 'CV'
USUBJID Unique Subject Identifier Char Concatenate ECHO.PROJECT and ECHO.SUBJECT with a hyphen in between.
CVSEQ Sequence Number Num Sort the records by USUBJID, CVDTC, VISITNUM, VISIT, CVSPID and assign as 1 on the first record of each subject and increment by 1 for each subsequent record for that subject.
CVSPID Sponsor-Defined Identifier Char Populate using ECHO.RECORDPOSITION in three digit format padding with leading 0's where applicable.
CVTESTCD Short Name of Cardiovascular Test Char Create one record for each test collected. Populate as 'LVEF' when creating the record using 'LVEF'. Populate as 'RVEF_E' when creating the record using 'RVEF'. Populate as 'CVALL' when creating the record where ECHO.ECHO_YN='No'.
testcds
CVTEST Name of Cardiovascular Test Char Populate as 'Left Ventricular Ejection Fraction' when CVTESTCD='LVEF'. Populate as 'Right Ventricular Ejection Fraction, Est' when CVTESTCD='RVEF_E'. Populate as 'Cardiovascular Test Results' when CVTESTCD='CVALL'.
CVCAT Category for Cardiovascular Test Char Set to 'ECHOCARDIOGRAM'
CVORRES Result or Finding in Original Units Char Populate using ECHO.LVEF, ECHO.RVEF
CVORRESU Original Units Char Set to '%' when CVORRES is not null.
CVSTRESC Character Result/Finding in Std Format Char Populate using SDTM.CV.CVORRES
CVSTRESN Numeric Result/Finding in Standard Units Num Convert SDTM.CV.CVSTRESC to numeric value where applicable.
CVSTRESU Standard Units Char Populate using SDTM.CV.CVORRESU
CVSTAT Completion Status Char Set to 'NOT DONE' when ECHO.ECHO_YN='No'. Set to 'NOT DONE' when ECHO.LVEF is missing when creating LVEF test. Set to 'NOT DONE' when ECHO.RVEF is missing when creating RVEF_E test.
CVREASND Reason Not Done Char Set to 'Not Collected' when SDTM.CV.CVSTAT='NOT DONE'
CVMETHOD Method of Test or Examination Char Set to 'ECHOCARDIOGRAM'
CVBLFL Baseline Flag Char Set to "Y" on the latest record with non-missing result on or prior to SDTM.DM.RFSTDTC per each test.
VISITNUM Visit Number Num Populate using FOLDERSEQ for scheduled visits. For unscheduled visits, add.01 to the previous scheduled or unscheduled visit number and assign the value assign the value as 'x.xx' (for programming purposes, use SDTM.SV dataset to get the VISITNUM associated with the unscheduled visit date).
VISIT Visit Name Char Populate using FOLDERNAME after converting to upper case for scheduled visits. For unscheduled visits, add 1 to the previous scheduled or unscheduled visit number and assign the value as the prior scheduled visit name with ' - Unscheduled x' added where x reflects the unscheduled visit number (for programming purposes, use SDTM.SV dataset to get the VISIT associated with the unscheduled visit date).
uns map
EPOCH Epoch Char Populate using SDTM.SE.EPOCH by comparing CVDTC with SESTDTC and SEENDTC of each element of the subject. Populate as 'SCREENING' when the record falls on the boundary of SCREENING and TREATMENT elements. Populate as 'TREATMENT' when the record falls on the boundary of TREATMENT and FOLLOW-UP.
epoch
CVDTC Date/Time of Test Char Populate using ECHO.ECHODAT in ISO 8601 format.
CVDY Study Day of Visit/Collection/Exam Num If the SDTM.CV.CVDTC is on or after reference start date then SDTM.CVSTDTC-SDTM.DM.RFSTDTC +1. Else if date is before reference start date then assign as SDTM.CM.CVSTDTC-SDTM.DM.RFSTDTC.
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