ID

30816

Beskrivning

Randomised Ischaemic Mitral Evaluation (RIME) Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00413998

Länk

https://clinicaltrials.gov/show/NCT00413998

Nyckelord

Versioner (1)
  1. 2018-06-22 2018-06-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Mitral Regurgitation NCT00413998

Engelsk

Eligibility Mitral Regurgitation NCT00413998

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients undergoing cabg.
Beskrivning

Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0010055
2. patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.
Beskrivning

Ischaemic mitral regurgitation Functional Moderate | Mitral Valve Prolapse Syndrome Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4087284
UMLS CUI [1,2]
C0205245
UMLS CUI [1,3]
C0205081
UMLS CUI [2,1]
C0026267
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with severe lv dysfunction (ef less than 30%).
Beskrivning

Left Ventricular Dysfunction Severe | Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242698
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0232174
2. patients with associated significant aortic valve disease.
Beskrivning

Aortic valve disorder Associated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1260873
UMLS CUI [1,2]
C0332281
3. patients with significant co-morbidities: renal impairment (creatinine > 160), liver impairment (inr > 2.0, bilirubin > 40), or underlying chronic obstructive lung disease (fev1:fvc ratio < 0.6).
Beskrivning

Comorbidity | Renal Insufficiency | Creatinine measurement, serum | Liver Dysfunction | INR | Serum total bilirubin measurement | Chronic Obstructive Airway Disease | FEV1/FVC ratio

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0086565
UMLS CUI [5]
C0525032
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0024117
UMLS CUI [8]
C0429745
4. patients with nyha class iv symptoms, unstable angina, acute pulmonary oedema or cardiogenic shock.
Beskrivning

Symptoms New York Heart Association Classification | Angina, Unstable | Pulmonary Edema | Shock, Cardiogenic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0034063
UMLS CUI [4]
C0036980
5. patients unsuitable for surgery e.g. patients with advanced malignancy, unable to give informed consent.
Beskrivning

Patients Inappropriate Operative Surgical Procedures | Malignant Neoplasms Advanced | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205179
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
6. patients with structural abnormalities of the mitral valve e.g. papillary muscle rupture, chordal rupture, etc.
Beskrivning

Mitral Valve Abnormality structural | Rupture of papillary muscle | Chorda tendinea Rupture

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026264
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0678594
UMLS CUI [2]
C0155713
UMLS CUI [3,1]
C0008484
UMLS CUI [3,2]
C3203359
7. patients with associated conditions which would significantly increase the risk of surgery.
Beskrivning

Condition Increase Risk Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0442805
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0543467
8. patients who have had previous cardiac surgery.
Beskrivning

Cardiac Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0018821
9. patients with a previous history of endocarditis
Beskrivning

Endocarditis

Datatyp

boolean

Alias
UMLS CUI [1]
C0014118
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Similar models

Eligibility Mitral Regurgitation NCT00413998

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Coronary Artery Bypass Surgery
Item
1. patients undergoing cabg.
boolean
C0010055 (UMLS CUI [1])
Ischaemic mitral regurgitation Functional Moderate | Mitral Valve Prolapse Syndrome Absent
Item
2. patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse.
boolean
C4087284 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C0026267 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Left Ventricular Dysfunction Severe | Cardiac ejection fraction
Item
1. patients with severe lv dysfunction (ef less than 30%).
boolean
C0242698 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2])
Aortic valve disorder Associated
Item
2. patients with associated significant aortic valve disease.
boolean
C1260873 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
Comorbidity | Renal Insufficiency | Creatinine measurement, serum | Liver Dysfunction | INR | Serum total bilirubin measurement | Chronic Obstructive Airway Disease | FEV1/FVC ratio
Item
3. patients with significant co-morbidities: renal impairment (creatinine > 160), liver impairment (inr > 2.0, bilirubin > 40), or underlying chronic obstructive lung disease (fev1:fvc ratio < 0.6).
boolean
C0009488 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0086565 (UMLS CUI [4])
C0525032 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0024117 (UMLS CUI [7])
C0429745 (UMLS CUI [8])
Symptoms New York Heart Association Classification | Angina, Unstable | Pulmonary Edema | Shock, Cardiogenic
Item
4. patients with nyha class iv symptoms, unstable angina, acute pulmonary oedema or cardiogenic shock.
boolean
C1457887 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0034063 (UMLS CUI [3])
C0036980 (UMLS CUI [4])
Patients Inappropriate Operative Surgical Procedures | Malignant Neoplasms Advanced | Informed Consent Unable
Item
5. patients unsuitable for surgery e.g. patients with advanced malignancy, unable to give informed consent.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Mitral Valve Abnormality structural | Rupture of papillary muscle | Chorda tendinea Rupture
Item
6. patients with structural abnormalities of the mitral valve e.g. papillary muscle rupture, chordal rupture, etc.
boolean
C0026264 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0678594 (UMLS CUI [1,3])
C0155713 (UMLS CUI [2])
C0008484 (UMLS CUI [3,1])
C3203359 (UMLS CUI [3,2])
Condition Increase Risk Operative Surgical Procedures
Item
7. patients with associated conditions which would significantly increase the risk of surgery.
boolean
C0348080 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
Cardiac Surgery
Item
8. patients who have had previous cardiac surgery.
boolean
C0018821 (UMLS CUI [1])
Endocarditis
Item
9. patients with a previous history of endocarditis
boolean
C0014118 (UMLS CUI [1])
Tillbaka till toppen 

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