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Description
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Data Structures with shared data
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ECG Results

ecg

01

Clinical Trials: ECG Results

Download Definition as
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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*guid
src_subject_idString20RequiredSubject ID how it's defined in lab/projectCATIEID, case_id, patid, randid, stepid, subject_id, subjectid, subjid
interview_ageIntegerRequiredAge in months at the time of the interview/test/sampling/imaging.0 :: 1260Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.bslage, intvage
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired fieldecgdt, ekg002, intvdate, visit_date
genderString20RequiredSex of the subjectM;FM = Male; F = Female
visitidIntegerRecommendedMetaTrial Visit IDSystem variable: unique code for each type of visit -use to merge files
visitString50RecommendedVisit nameCharacter description of each type of visitekg_interval, int1, interval, visit_name
truncvisIntegerRecommendedTruncated Visit NumberCreated variable: provides a numeric visit number for all visits, including unscheduled and end of phase
phase_ctString20RecommendedCurrent Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase.Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1phase
visdayIntegerRecommendedNumber of days from study baseline to date of visitekg_visitdat_x
ecgtmString15RecommendedECG Time
ecgintIntegerRecommendedPhysician Interpretation1::4;71=Normal; 2=Abnormal (not clinically significant); 3=Abnormal (clinically significant); 4=Uninterpretable; 7=Incomplete Analysisfuekgq1_no
diag1String50RecommendedDiagnosis 1Interpretation from the central ECG center
diag2String50RecommendedDiagnosis 2Diagnosis from the central ECG center
diag3String50RecommendedDiagnosis 3Diagnosis from the central ECG center
diag4String250RecommendedDiagnosis
diag5String50RecommendedDiagnosis 5Diagnosis from the central ECG center
diag6String50RecommendedDiagnosis 6Diagnosis from the central ECG center
diag7String50RecommendedDiagnosis 7Diagnosis from the central ECG center
diag8String50RecommendedDiagnosis 8Diagnosis from the central ECG center
diag9String50RecommendedDiagnosis 9Diagnosis from the central ECG center
diag10String50RecommendedDiagnosis 10Diagnosis from the central ECG center
ecghrIntegerRecommendedECG HRbslhr_no, ekg1, hrtrtvl
ecgprIntegerRecommendedECG PRbslpr_no, ekg2, printvl
ecgqrsIntegerRecommendedECG QRSbslqrs_no, ekg3, qrsdurvl
ecgqtIntegerRecommendedECG QTbslqt_no, ekg4, qtintvl
ecgqtcFloatRecommendedECG QTCekg5, qtcfint, qtcform
ecgaxisIntegerRecommendedECG AXIS
crfintIntegerRecommended1. ECG Result
0::3
0=Normal;1=Abnormal, Not Clinically Significant;2= Abnormal, Clinically Significant; 3=not assessedecg003, ecgnorm, ecgread, ekg003, ekg9, ekg_q02
base11a_ecgIntegerRecommendedPh1/1A Baseline ECG Interpretaion1::31= Normal; 2= Abnormal (not clinically significant); 3= Abnormal (clinically significant)BASE11A, base1
base1b_ecgIntegerRecommendedPh1B Baseline ECG Interpretaion1::31= Normal; 2= Abnormal (not clinically significant); 3= Abnormal (clinically significant)BASE1B
base2_ecgIntegerRecommendedPh2 Baseline ECG Interpretaion1::31= Normal; 2= Abnormal (not clinically significant); 3= Abnormal (clinically significant)BASE2
base3_ecgIntegerRecommendedPh3 Baseline ECG Interpretaion1::31= Normal; 2= Abnormal (not clinically significant); 3= Abnormal (clinically significant)BASE3
b1_qtIntegerRecommendedPh1/1A Baseline ECG QT Length
b1b_qtIntegerRecommendedPh1B Baseline ECG QT Length
b2_qtIntegerRecommendedPh2 Baseline ECG QT Length
b3_qtIntegerRecommendedPh3 Baseline ECG QT Length
ilast11aIntegerRecommendedIndicator Last Interpretation Ph1/1A11=Yes for all records meeting this criteriailast1
ilast1bIntegerRecommendedIndicator Last Interpretation Ph1b11=Yes for all records meeting this criteria
ilast2IntegerRecommendedIndicator Last Interpretation Ph211=Yes for all records meeting this criteria
ilast3IntegerRecommendedIndicator Last Interpretation Ph311=Yes for all records meeting this criteria
qtlst11aIntegerRecommendedIndicator Last QT Length Ph1/1A11=Yes for all records meeting this criteria
qtlst1bIntegerRecommendedIndicator Last QT Length Ph1b11=Yes for all records meeting this criteria
qtlst2IntegerRecommendedIndicator Last QT Length Ph211=Yes for all records meeting this criteria
qtlst3IntegerRecommendedIndicator Last QT Length Ph311=Yes for all records meeting this criteria
csphaseIntegerRecommendedIndicator for CS ECG where Base# not CS11=Yes for all records meeting this criteria
c_qtIntegerRecommendedPhase Specific CFB for QT LengthPhase-specific change (within each phase, change is calculated from that phase's baseline measurement)
csprevIntegerRecommendedIndicator for CS ECG when last ECG not C11= if patient has a clinically significant post-baseline ECG, and their previous ECG within that phase was not clinically significant; missing otherwise
prolqtc1IntegerRecommendedProlonged QTC in Phase 1/1A11= if patient is (male and has a QTC value > 450 and has a non-missing baseline QTC value <= 450) or (female and has a QTC value > 470 and has a non-missing baseline QTC value <= 470); missing otherwise
certcodeIntegerRecommendedstepbd certification code
daysrzIntegerRecommendeddays since randomizationstudyday, testrz
lahyperIntegerRecommendedleft arterial hypertrophy0;1;-70=No; 1=Yes; -7=Refusedec_q1_1, ekg_q04, fuekgq1_1
rahyperIntegerRecommendedright arterial hypertrophy0;1;-70=No; 1=Yes; -7=Refusedec_q1_2, ekg_q05, fuekgq1_2
lvhyperIntegerRecommendedleft ventricular hypertrophy0;1;-70=No; 1=Yes; -7=Refusedec_q1_3, ekg_q06, fuekgq1_3
rvhyperIntegerRecommendedright ventricular hypertrophy0;1;-70=No; 1=Yes; -7=Refusedec_q1_4, ekg_q07, fuekgq1_4
acinfIntegerRecommendedacute infarction0;1;-70=No; 1=Yes; -7=Refusedai, ec_q1_5, ekg_q08, fuekgq1_5
subacinfIntegerRecommendedsubacute infarction0;1;-70=No; 1=Yes; -7=Refusedec_q1_6, ekg_q09, fuekgq1_6, si
oldinfIntegerRecommendedold infarction0;1;-70=No; 1=Yes; -7=Refusedec_q1_7, ekg_q10, fuekgq1_7, oi
myocinfIntegerRecommendedmyocardial ischemia0;1;-70=No; 1=Yes; -7=Refusedec_q1_8, ekg_q11, fuekgq1_8, mi
digitalIntegerRecommendeddigitalis effect0;1;-70=No; 1=Yes; -7=Refusedec_q1_9, ekg_q12, fuekgq1_9
twaveIntegerRecommendedsymmetrical t wave inversions0;1;-70=No; 1=Yes; -7=Refusedec_q1_10, ekg_q13, fuekgq1_10
rwaveIntegerRecommendedpoor r wave progression0;1;-70=No; 1=Yes; -7=Refusedec_q1_11, ekg_q14, fuekgq1_11
sttIntegerRecommendedother non specific st/t0;1;-70=No; 1=Yes; -7=Refusedec_q1_12, ekg_q15, fuekgq1_12
sinustIntegerRecommendedsinus tachycardia0;1;-70=No; 1=Yes; -7=Refusedec_q1_13, ekg_q16, fuekgq1_13
sinusbIntegerRecommendedsinus bradycardia0;1;-70=No; 1=Yes; -7=Refusedec_q1_14, ekg_q17, fuekgq1_14
spbeatIntegerRecommendedsupraventric premature beat0;1;-70=No; 1=Yes; -7=Refusedec_q1_15, ekg_q18, fuekgq1_15
vpbeatIntegerRecommendedventricular premature beat0;1;-70=No; 1=Yes; -7=Refusedec_q1_16, ekg_q19, fuekgq1_16
stachyIntegerRecommendedsupraventricular tachycardia0;1;-70=No; 1=Yes; -7=Refusedec_q1_17, ekg_q20, fuekgq1_17
vtachyIntegerRecommendedventricular tachycardia0;1;-70=No; 1=Yes; -7=Refusedec_q1_18, ekg_q21, fuekgq1_18
afibIntegerRecommendedatrial fibrillation0;1;-70=No; 1=Yes; -7=Refusedec_q1_19, ekg_q22, fuekgq1_19
aflutterIntegerRecommendedatrial flutter0;1;-70=No; 1=Yes; -7=Refusedec_q1_20, ekg_q23, fuekgq1_20
rhythmIntegerRecommendedother rhythm abnormalities0;1;-70=No; 1=Yes; -7=Refusedec_q1_21, ekg_q24, fuekgq1_21
pacemakeIntegerRecommendedimplanted pacemaker0;1;-70=No; 1=Yes; -7=Refusedec_q1_22, ekg_q25, fuekgq1_22
av1stIntegerRecommended1st degree av block0;1;-70=No; 1=Yes; -7=Refusedec_q1_23, ekg_q26, fuekgq1_23
av2ndIntegerRecommended2nd degree av block0;1;-70=No; 1=Yes; -7=Refusedec_q1_24, ekg_q27, fuekgq1_24
av3rdIntegerRecommended3rd degree av block0;1;-70=No; 1=Yes; -7=Refusedec_q1_25, ekg_q28, fuekgq1_25
lbbIntegerRecommendedlbb block0;1;-70=No; 1=Yes; -7=Refusedec_q1_26, ekg_q29, fuekgq1_26
rbbIntegerRecommendedrbb block0;1;-70=No; 1=Yes; -7=Refusedec_q1_27, ekg_q30, fuekgq1_27
pesyndIntegerRecommendedpre excitation syndrome0;1;-70=No; 1=Yes; -7=Refusedec_q1_28, ekg_q31, fuekgq1_28
oicondIntegerRecommendedother intraventric cond block0;1;-70=No; 1=Yes; -7=Refusedec_q1_29, ekg_q32, fuekgq1_29
oabnIntegerRecommendedother abnormality0;1;-70=No; 1=Yes; -7=Refusedec_q1_30, ekg_q33, fuekgq1_30
siteString100RecommendedSiteStudy Sitesite_id, site_no, site_uid, siteid
bslhr_rptIntegerRecommendedEKG lab value repeated - HR1;21=no;2=yes
bslpr_rptIntegerRecommendedEKG lab value repeated - PR1;21=no;2=yes
bslqrs_rptIntegerRecommendedEKG lab value repeated - QRS1;21=no;2=yes
bslqt_rptIntegerRecommendedEKG lab value repeated - QTc1;21=no;2=yes
trt_grpString10RecommendedTreatment Group Assignment1;1AO;1CT;2;31=Group 1 first 8 weeks; 1AO=Group 1 8 week add on; 1CT=Group 1 8 week cross taper; 2=Group 2; 3=Group 3
days_baselineIntegerRecommendedDays since baselinebsldays
etypeString10RecommendedRating PeriodBSL;WK1;WK2;WK3;WK4;WK5;WK6;WK7;WK8;WK9;WK10;WK11;WK12;WK13;WK14;WK15;WK16BSL=Baseline; WK1-WK16=Weeks 1-16
respond_detail_oth_specString255RecommendedRespondent detailsinformnt
relationshipString255RecommendedRelationship of respondent to individual
1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19;20;21;22;23;24;25;26;27;28;29;30;31;32;33;34;35;36;37;38;39;40;41;42;43;44;45;46;47;48;49;50;51;52;53;54;55;56;57;58;59;60;61;62;63;64;65;66;67;68;69;70;71;72;73;74;75;76;77;78;79;80;81;82;83;84; -999
1 = Biological mom; 2 = Biological dad; 3 = Grandparent; 4 = Special education (sped) teacher; 5 = General education teacher; 6 = Occupational therapist; 7 = Speech and language therapist; 8 = Behavioral therapist; 9 = Paraprofessional; 10 = Aide; 11 = Principal; 12 = Administrator; 13 = Other; 14 = Content teacher; 15 = Parent center director; 16 = Self; 17=Adoptive mother; 18=Adoptive father; 19=Foster mother; 20 = Foster father; 21=Grandmother; 22=Grandfather; 23=Step-mother; 24 = Step-father; 25=Aunt; 26=Uncle; 27=Missing Data; 28=Both parents;31= Grandmother from mother side; 32= Grandfather from mother side; 33= Grandmother from father side; 34= Grandfather from father side; 36= Brother; 37= Sister; 38= Cousin; 39= female caregiver; 40=male caregiver; 41=Female child; 42=Male child; 43=Spouse/Mate; 44=Friend; 45=Parent; 46=Significant other; 47=Sibling; 48=Son/Daughter; 49=Son-in-law/Daughter-in law; 50=Other Relative; 51=Paid caregiver; 52=Friends; 90= Other, specify; -999= Missing; 53=Roommate; 54=Supervisor; 55=mother's boyfriend; 56=other parental figure; 57=Summary; 58=counselor ; 59 = other female relative; 60 = other male relative; 61 = non-relative ;62=Maternal Aunt; 63=Maternal Uncle; 64=Maternal Cousin; 65 = Paternal Aunt; 66=Paternal Uncle; 67=Paternal Cousin ;68=Biological/Adoptive Mother and Grandmother; 69=Biological/Adoptive Mother and Stepmother and Grandmother; 70=Biological/Adoptive Mother and Grandmother and Foster Father; 71=Biological/Adoptive Mother and Stepmother and Foster Mother; 72=Biological/Adoptive Mother and Foster Mother; 73=Biological/Adoptive Mother and Biological/Adoptive Father; 74=Biological/Adoptive Mother and Stepmother and Biological/Adoptive Father; 75=Biological/Adoptive Mother and Other; 76=Biological/Adoptive Mother and Stepmother and Stepfather; 77=Biological/Adoptive Mother and Stepfather; 78=Biological/Adoptive Mother and Grandfather; 79=Biological/Adoptive Mother and Stepmother and Foster Father; 80=Biological/Adoptive Mother and Stepmother; 81=Guardian, female; 82=Other female; 83=Guardian, male; 84=Other maleinfrmnt2
study_drug_teamString30RecommendedStudy drugBaseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
ekg001IntegerRecommendedWas an EKG performed on this subject?0;10=No; 1=Yesecg001, ekg_q01, q01, status
ekg004String250RecommendedDescribe abnormalities: (At screening, justify enrollment of subject. At weeks 4 or 6, enter AE.)ecg003a
studyString100RecommendedStudyekg_studyid, studyid
completedIntegerRecommendedChecks if form is completed0::20=No; 1=Yes; 2=Yes, lostekg_frmcomp, formcomp, frmcomp
subtrial_nameIntegerRecommendedName of subtrial1::31=Crossover; 2=Guanfacine; 3= Open Label MPH
ec_q1_noIntegerRecommendedNo Abnormalities11=No Abnormalities
ec_q2IntegerRecommendedDo items exclude individual from study0;10=No; 1=Yesekg_q34, fuekgq1_34
datereadIntegerRecommendedDate the ECG was read in days from the randomization date
session_idString20Recommendedsession ID/screening IDscreeningid
version_formString100RecommendedForm usedform_name
ecgstrthIntegerRecommendedECG Start Time Hours
ecgstrtmIntegerRecommendedECG Start Time Minutes
ecgendthIntegerRecommendedECG End Time Hours
ecgendtmIntegerRecommendedECG End Time Minutes
ecgtypIntegerRecommendedECG Type1::31=3 Lead; 2=5 Lead; 3=12 Lead (required at screening)
rrintvlFloatRecommendedRR Interval Value
comments_miscString4,000RecommendedMiscellaneous comments on study, interview, methodology relevant to this form dataecgcmnt
visnumFloatRecommendedNumeric Visit Number-1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; 1000=all visits
lab020DateRecommendedDate of PI/clinician signatureecg004
comp_assessIntegerRecommendedPlease indicated when assessment completed1;2;-91=Pre-infusion; 2=Post-infusion; -9=Unknownecg00a
date_updatedDateRecommendedDate record updatededit_date
trtgroupString2RecommendedTreatment GroupN1;N2;R1;R2;R3N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
weekFloatRecommendedWeek in level/study99=week 10-week 14intid
study_idIntegerRecommendedStudy ID number46=Acute Phase; 47=Stabilization Phase
ecgdoneString2RecommendedWas ECG performed at this assessment?Y;N
subj_posString20RecommendedPosition of subjectSitting; Supine; Prone; Standingecgpos
ncsspecString100RecommendedSpecify Abnormal, not clinically significant result
csspecString100RecommendedSpecify Abnormal, clinically significant result
ci_enrolledIntegerRecommendedParticipant enrolled0;10=No; 1=Yesenrolled
sitedatasource_1IntegerRecommendedSource of Data: Site0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;infosrcr
sitedatasource_phoneIntegerRecommendedSource of Data: Telephone0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;infosrct
sitedatasource_physicianIntegerRecommendedSource of Data: Physician0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;infosrcp
ecg_pIntegerRecommendedP axis
ecg_rIntegerRecommendedR axis
ecg_tIntegerRecommendedT axis
heart_rateIntegerRecommendedheart rate
ecg_hrldFloatRecommendedECG: Hours since last dose
ecg_nrmlIntegerRecommendedECG: Normal - yes (1) or no (0)?0; 1; -8880 = No; 1 = Yes; -888= NA
ecg_sgchIntegerRecommendedECG: Significant change - yes (1) or no?0; 1; -8880 = No; 1 = Yes; -888= NA
ecg_sfprIntegerRecommendedECG: Do any values exceed safety parameters?0; 10 = No; 1 = Yes
ecg_cardiacIntegerRecommendedECG: Cardiac Consult Action Taken0; 10 = No; 1 = Yes
ecg_wthdrawnIntegerRecommendedECG: Withdrawn Action Taken0; 10 = No; 1 = Yes
ecg_wdrawdteIntegerRecommendedECG: Withdrawn Date if Applicable (days offset from randomization date)Offset from randomization date (days)
me2IntegerRecommendedStatus0;10 = Past [Inactive]; 1 = Active
ekgIntegerRecommendedekg normal abnormal1;21=Within normal range; 2=Out of range
midihist_008aString250RecommendedOther cardiac describe
sigp1IntegerRecommendedPhysician signature present0;10 = No; 1 = Yes
sigd1IntegerRecommendedPhysician/PI signature date (days since randomization)
ecgrdbyIntegerRecommendedECG Read By:1::41 = Computer; 2 = Hand; 3 = ECG not readable; 4 = Computer & Hand (double check)
qtchndIntegerRecommendedQTC value: rechecked by hand
qthndIntegerRecommendedQT value: rechecked by hand
q71ckIntegerRecommendedLeft Atrial Hypertrophy0;10 = No; 1 = Yes
q73ckIntegerRecommendedRight Atrial Hypertrophy0;10 = No; 1 = Yes
quest71IntegerRecommendedAbnormality Clinically Significant? Left Atrial Hypertrophy0;10 = No; 1 = Yes
quest75IntegerRecommendedAbnormality Clinically Significant? Left Ventricular Hypertrophy0;10 = No; 1 = Yes
quest77IntegerRecommendedAbnormality Clinically Significant? Right Ventricular Hypertrophy0;10 = No; 1 = Yes
quest712IntegerRecommendedAbnormality Clinically Significant? Other rhythm abnormalities?0;10 = No; 1 = Yes
quest722IntegerRecommendedAbnormality Clinically Significant? LBB Block0;10 = No; 1 = Yes
quest723IntegerRecommendedAbnormality Clinically Significant? Other Non-specific ST/T0;10 = No; 1 = Yes
quest724IntegerRecommendedAbnormality Clinically Significant? RBB Block0;10 = No; 1 = Yes
quest725IntegerRecommendedAbnormality Clinically Significant? Sinus Tachycardia0;10 = No; 1 = Yes
quest728IntegerRecommendedAbnormality Clinically Significant? Other Intraventricular Cond. Block0;10 = No; 1 = Yes
quest729IntegerRecommendedAbnormality Clinically Significant? Supraventric premature beat0;10 = No; 1 = Yes
quest730IntegerRecommendedAbnormality Clinically Significant? Other0;10 = No; 1 = Yes
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

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  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
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  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
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Distribution for DataStructure: ecg01 and Element:
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