ID

30821

Beskrivning

Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation; ODM derived from: https://clinicaltrials.gov/show/NCT00807040

Länk

https://clinicaltrials.gov/show/NCT00807040

Nyckelord

Versioner (1)
  1. 2018-06-23 2018-06-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Mitral Valve Insufficiency NCT00807040

Engelsk

Eligibility Mitral Valve Insufficiency NCT00807040

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic severe ischemic mitral regurgitation (often with tethering as a major mechanism) in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. assessment of mitral regurgitation will be performed using an integrative method (zoghbi w. et al. j. american society of echocardiography. 2003:16:777-802. see appendix). quantitative guidelines as proposed would be: ero ≥ 0.4 cmsq. if ero < 0.4, then the degree of mitral regurgitation will be guided by other color doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive criteria in an integrated fashion
Beskrivning

Ischaemic mitral regurgitation Severe chronic Transthoracic echocardiography | Effective Regurgitant Orifice Area | Echocardiography, Doppler, Color | Mitral Regurgitant Jet Area to Left Atrial Area Ratio | Vena contracta

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4087284
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205191
UMLS CUI [1,4]
C0430462
UMLS CUI [2]
C4264252
UMLS CUI [3]
C0013521
UMLS CUI [4]
C4288733
UMLS CUI [5]
C2732913
eligible for surgical repair and replacement of mitral valve
Beskrivning

Eligibility Mitral valvuloplasty | Eligibility Replacement of mitral valve

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0396849
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0026268
cad with or without the need for coronary revascularization
Beskrivning

Coronary Artery Disease | Patient need for Coronary revascularisation | Absence Need Coronary revascularisation

Datatyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0877341
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0027552
UMLS CUI [3,3]
C0877341
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any evidence of structural (chordal or leaflet) mitral valve disease or ruptured papillary muscle
Beskrivning

Diseases of mitral valve structural | Diseases of mitral valve Chorda tendinea | Diseases of mitral valve Leaflet | Mitral papillary muscle rupture

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026265
UMLS CUI [1,2]
C0678594
UMLS CUI [2,1]
C0026265
UMLS CUI [2,2]
C0008484
UMLS CUI [3,1]
C0026265
UMLS CUI [3,2]
C0447009
UMLS CUI [4]
C0238414
prior mitral valve repair
Beskrivning

Mitral valvuloplasty Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0396849
UMLS CUI [1,2]
C0205156
severe irreversible pulmonary hypertension in the judgment of the investigator
Beskrivning

Pulmonary Hypertension Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0205082
medically unable to undergo cardiopulmonary bypass (cpb)
Beskrivning

Cardiopulmonary Bypass Receive Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007202
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
inability to derive ero and end-systolic volume index (esvi) by transthoracic echocardiography
Beskrivning

Effective Regurgitant Orifice Area Transthoracic echocardiography Unsuccessful | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4264252
UMLS CUI [1,2]
C0430462
UMLS CUI [1,3]
C1272705
UMLS CUI [2]
C3846158
planned concomitant intra-operative procedures (with the exception of tricuspid valve repair, closure of patent foramen ovale [pfo] or atrial septal defect [asd] or maze procedure)
Beskrivning

Intraoperative procedures Planned | Exception Repair of tricuspid valve | Exception Closure of patent foramen ovale | Exception Atrioseptoplasty | Exception Surgical Maze Procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243164
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0396899
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0189967
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0189965
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C3272262
clinical signs of cardiogenic shock at the time of surgery
Beskrivning

Sign or Symptom Cardiogenic Shock

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0036980
treatment with long-term intravenous inotropic therapy at the time of surgery
Beskrivning

Inotropic agent Intravenous Long-term

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0443252
st segment elevation myocardial infarction (mi) requiring intervention in the 7 days before surgery
Beskrivning

ST segment elevation myocardial infarction Requirement Intervention

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0184661
congenital heart disease (except pfo or asd)
Beskrivning

Congenital heart disease | Exception Patent Foramen Ovale | Exception Atrial Septal Defects

Datatyp

boolean

Alias
UMLS CUI [1]
C0152021
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0016522
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0018817
evidence of cirrhosis or liver synthetic failure
Beskrivning

Liver Cirrhosis | Liver synthetic function Failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C4313898
UMLS CUI [2,2]
C0231174
excessive surgical risk, as judged by the surgical investigator
Beskrivning

Risk Surgical Excessive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0442802
recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, as judged by the investigator
Beskrivning

Mental disorders Impairing Protocol Compliance | Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0525058
UMLS CUI [2]
C0038586
therapy with an investigational intervention at the time of screening, or planning to enroll in an additional investigational intervention study during participation in this study
Beskrivning

Intervention Investigational | Study Subject Participation Status | Intervention Investigational Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1517586
UMLS CUI [2]
C2348568
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C1517586
UMLS CUI [3,3]
C1524062
any concurrent disease with a life expectancy of less than 2 years
Beskrivning

Comorbidity | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0023671
pregnant
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Mitral Valve Insufficiency NCT00807040

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Ischaemic mitral regurgitation Severe chronic Transthoracic echocardiography | Effective Regurgitant Orifice Area | Echocardiography, Doppler, Color | Mitral Regurgitant Jet Area to Left Atrial Area Ratio | Vena contracta
Item
chronic severe ischemic mitral regurgitation (often with tethering as a major mechanism) in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. assessment of mitral regurgitation will be performed using an integrative method (zoghbi w. et al. j. american society of echocardiography. 2003:16:777-802. see appendix). quantitative guidelines as proposed would be: ero ≥ 0.4 cmsq. if ero < 0.4, then the degree of mitral regurgitation will be guided by other color doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive criteria in an integrated fashion
boolean
C4087284 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0430462 (UMLS CUI [1,4])
C4264252 (UMLS CUI [2])
C0013521 (UMLS CUI [3])
C4288733 (UMLS CUI [4])
C2732913 (UMLS CUI [5])
Eligibility Mitral valvuloplasty | Eligibility Replacement of mitral valve
Item
eligible for surgical repair and replacement of mitral valve
boolean
C1548635 (UMLS CUI [1,1])
C0396849 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0026268 (UMLS CUI [2,2])
Coronary Artery Disease | Patient need for Coronary revascularisation | Absence Need Coronary revascularisation
Item
cad with or without the need for coronary revascularization
boolean
C1956346 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0877341 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0027552 (UMLS CUI [3,2])
C0877341 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Diseases of mitral valve structural | Diseases of mitral valve Chorda tendinea | Diseases of mitral valve Leaflet | Mitral papillary muscle rupture
Item
any evidence of structural (chordal or leaflet) mitral valve disease or ruptured papillary muscle
boolean
C0026265 (UMLS CUI [1,1])
C0678594 (UMLS CUI [1,2])
C0026265 (UMLS CUI [2,1])
C0008484 (UMLS CUI [2,2])
C0026265 (UMLS CUI [3,1])
C0447009 (UMLS CUI [3,2])
C0238414 (UMLS CUI [4])
Mitral valvuloplasty Previous
Item
prior mitral valve repair
boolean
C0396849 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pulmonary Hypertension Severe
Item
severe irreversible pulmonary hypertension in the judgment of the investigator
boolean
C0020542 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cardiopulmonary Bypass Receive Unable
Item
medically unable to undergo cardiopulmonary bypass (cpb)
boolean
C0007202 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Effective Regurgitant Orifice Area Transthoracic echocardiography Unsuccessful | Other Coding
Item
inability to derive ero and end-systolic volume index (esvi) by transthoracic echocardiography
boolean
C4264252 (UMLS CUI [1,1])
C0430462 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Intraoperative procedures Planned | Exception Repair of tricuspid valve | Exception Closure of patent foramen ovale | Exception Atrioseptoplasty | Exception Surgical Maze Procedure
Item
planned concomitant intra-operative procedures (with the exception of tricuspid valve repair, closure of patent foramen ovale [pfo] or atrial septal defect [asd] or maze procedure)
boolean
C0243164 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0396899 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0189967 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0189965 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C3272262 (UMLS CUI [5,2])
Sign or Symptom Cardiogenic Shock
Item
clinical signs of cardiogenic shock at the time of surgery
boolean
C3540840 (UMLS CUI [1,1])
C0036980 (UMLS CUI [1,2])
Inotropic agent Intravenous Long-term
Item
treatment with long-term intravenous inotropic therapy at the time of surgery
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
ST segment elevation myocardial infarction Requirement Intervention
Item
st segment elevation myocardial infarction (mi) requiring intervention in the 7 days before surgery
boolean
C1536220 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Congenital heart disease | Exception Patent Foramen Ovale | Exception Atrial Septal Defects
Item
congenital heart disease (except pfo or asd)
boolean
C0152021 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0016522 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0018817 (UMLS CUI [3,2])
Liver Cirrhosis | Liver synthetic function Failure
Item
evidence of cirrhosis or liver synthetic failure
boolean
C0023890 (UMLS CUI [1])
C4313898 (UMLS CUI [2,1])
C0231174 (UMLS CUI [2,2])
Risk Surgical Excessive
Item
excessive surgical risk, as judged by the surgical investigator
boolean
C0035647 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0442802 (UMLS CUI [1,3])
Mental disorders Impairing Protocol Compliance | Substance Use Disorders
Item
recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, as judged by the investigator
boolean
C0004936 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2])
Intervention Investigational | Study Subject Participation Status | Intervention Investigational Additional
Item
therapy with an investigational intervention at the time of screening, or planning to enroll in an additional investigational intervention study during participation in this study
boolean
C0184661 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
C0184661 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C1524062 (UMLS CUI [3,3])
Comorbidity | Life Expectancy
Item
any concurrent disease with a life expectancy of less than 2 years
boolean
C0009488 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Pregnancy
Item
pregnant
boolean
C0032961 (UMLS CUI [1])
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