ID

30820

Description

Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation; ODM derived from: https://clinicaltrials.gov/show/NCT00806988

Link

https://clinicaltrials.gov/show/NCT00806988

Keywords

Versions (1)
  1. 6/22/18 6/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Mitral Valve Insufficiency NCT00806988

English

Eligibility Mitral Valve Insufficiency NCT00806988

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
moderate mitral regurgitation 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 between 0.2 cmsq to 0.39 cmsq. if ero < 0.2, 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
Description

Mitral Valve Insufficiency Moderate Transthoracic echocardiography | Effective Regurgitant Orifice Area | Echocardiography, Doppler, Color | Mitral Regurgitant Jet Area to Left Atrial Area Ratio | Vena contracta

Data type

boolean

Alias
UMLS CUI [1,1]
C0026266
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0430462
UMLS CUI [2]
C4264252
UMLS CUI [3]
C0013521
UMLS CUI [4]
C4288733
UMLS CUI [5]
C2732913
cad that is amenable to cabg and a clinical indication for revascularization
Description

Coronary Artery Disease Amenable Coronary Artery Bypass Surgery | Indication Revascularization

Data type

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0010055
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0581603
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any evidence of structural (chordal or leaflet) mitral valve disease
Description

Diseases of mitral valve structural | Diseases of mitral valve Chorda tendinea | Diseases of mitral valve Leaflet

Data type

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
inability to derive ero and end-systolic volume index (esvi) by transthoracic echocardiography
Description

Effective Regurgitant Orifice Area Transthoracic echocardiography Unsuccessful | Other Coding

Data type

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 closure of patent foramen ovale [pfo] or atrial septal defect [asd]or maze procedure or left atrial appendage excision)
Description

Intraoperative procedures Planned | Exception Closure of patent foramen ovale | Exception Atrioseptoplasty | Exception Surgical Maze Procedure | Exception Excision Left Atrial Appendage

Data type

boolean

Alias
UMLS CUI [1,1]
C0243164
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0189967
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0189965
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3272262
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0728940
UMLS CUI [5,3]
C4284918
prior surgical or percutaneous mitral valve repair
Description

Mitral valvuloplasty | Percutaneous Mitral Valve Repair

Data type

boolean

Alias
UMLS CUI [1]
C0396849
UMLS CUI [2]
C3272248
contraindication to cardiopulmonary bypass (cpb)
Description

Medical contraindication Cardiopulmonary Bypass

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0007202
clinical signs of cardiogenic shock at the time of surgery
Description

Sign or Symptom Cardiogenic Shock

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0036980
treatment with chronic intravenous inotropic therapy at the time of surgery
Description

Inotropic agent Intravenous chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0205191
severe, irreversible pulmonary hypertension in the judgment of the investigator
Description

Pulmonary Hypertension Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0205082
st segment elevation myocardial infarction (mi) requiring intervention in the 7 days before surgery
Description

ST segment elevation myocardial infarction Requirement Intervention

Data type

boolean

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

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

Data type

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
Description

Liver Cirrhosis | Liver synthetic function Failure

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C4313898
UMLS CUI [2,2]
C0231174
recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, in the judgment of the investigator
Description

Mental disorders Impairing Protocol Compliance | Substance Use Disorders

Data type

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 the study
Description

Intervention Investigational | Study Subject Participation Status | Intervention Investigational Additional

Data type

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
Description

Comorbidity | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0023671
pregnancy at the time of randomization
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Mitral Valve Insufficiency NCT00806988

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Mitral Valve Insufficiency Moderate Transthoracic echocardiography | Effective Regurgitant Orifice Area | Echocardiography, Doppler, Color | Mitral Regurgitant Jet Area to Left Atrial Area Ratio | Vena contracta
Item
moderate mitral regurgitation 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 between 0.2 cmsq to 0.39 cmsq. if ero < 0.2, 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
C0026266 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0430462 (UMLS CUI [1,3])
C4264252 (UMLS CUI [2])
C0013521 (UMLS CUI [3])
C4288733 (UMLS CUI [4])
C2732913 (UMLS CUI [5])
Coronary Artery Disease Amenable Coronary Artery Bypass Surgery | Indication Revascularization
Item
cad that is amenable to cabg and a clinical indication for revascularization
boolean
C1956346 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0581603 (UMLS CUI [2,2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diseases of mitral valve structural | Diseases of mitral valve Chorda tendinea | Diseases of mitral valve Leaflet
Item
any evidence of structural (chordal or leaflet) mitral valve disease
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])
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 Closure of patent foramen ovale | Exception Atrioseptoplasty | Exception Surgical Maze Procedure | Exception Excision Left Atrial Appendage
Item
planned concomitant intra-operative procedures (with the exception of closure of patent foramen ovale [pfo] or atrial septal defect [asd]or maze procedure or left atrial appendage excision)
boolean
C0243164 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0189967 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0189965 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C3272262 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0728940 (UMLS CUI [5,2])
C4284918 (UMLS CUI [5,3])
Mitral valvuloplasty | Percutaneous Mitral Valve Repair
Item
prior surgical or percutaneous mitral valve repair
boolean
C0396849 (UMLS CUI [1])
C3272248 (UMLS CUI [2])
Medical contraindication Cardiopulmonary Bypass
Item
contraindication to cardiopulmonary bypass (cpb)
boolean
C1301624 (UMLS CUI [1,1])
C0007202 (UMLS CUI [1,2])
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 chronic
Item
treatment with chronic intravenous inotropic therapy at the time of surgery
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
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])
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])
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, in the judgment of 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 the 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
pregnancy at the time of randomization
boolean
C0032961 (UMLS CUI [1])
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