ID

39443

Beschrijving

Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters; ODM derived from: https://clinicaltrials.gov/show/NCT01357408

Link

https://clinicaltrials.gov/show/NCT01357408

Trefwoorden

Versies (1)
  1. 10-01-20 10-01-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 januari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01357408

Engels

Eligibility Heart Failure NCT01357408

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and non-pregnant/non lactating women ≥ 18 years.
Beschrijving

Gender | Age | Pregnancy Absent | Breast Feeding Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C0332197
2. admission to hospital or observation unit for worsening heart failure.
Beschrijving

Hospital admission Heart failure Worsening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0332271
3. has a reveal xt device or has plans for a device implant for a clinical indication within 14 days of discharge.
Beschrijving

Heart Rate Monitoring System Specified | Indication Device implant

Datatype

boolean

Alias
UMLS CUI [1,1]
C4287153
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0948629
4. ejection fraction ≥40% by echocardiogram within 6 months of enrollment
Beschrijving

Cardiac ejection fraction Echocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
5. able to participate in the study for at least 6 months.
Beschrijving

Participation Clinical Trial Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0449238
6. not currently enrolled in another study.
Beschrijving

Absence Enrollment Clinical Trial Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205394
7. able to provide informed consent and complete scheduled study visits.
Beschrijving

Informed Consent | Clinical Trial Visits Completion

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0008952
UMLS CUI [2,3]
C0205197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. has a clinical indication for a therapeutic cardiac device (pacemaker or defibrillator)
Beschrijving

Indication Cardiac implant device | Indication Pacemaker | Indication Defibrillator

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0581396
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0030163
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0180307
2. history of permanent atrial fibrillation or atrial flutter.
Beschrijving

Permanent atrial fibrillation | Atrial Flutter Permanent

Datatype

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2,1]
C0004239
UMLS CUI [2,2]
C0205355
3. history of uncontrolled hypertension (high blood pressure)
Beschrijving

Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
4. has a previously implanted cardiac device (pacemaker or defibrillator) in place.
Beschrijving

Cardiac implant device Previous | Pacemaker Previous | Defibrillator Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0581396
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0030163
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0180307
UMLS CUI [3,2]
C0205156
5. stage iv or v chronic renal dysfunction (estimated gfr <25 ml/min per 1.73 m2)
Beschrijving

Renal dysfunction chronic Stage | Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C1306673
UMLS CUI [2]
C3811844
6. end-stage (stage d) hf, including chronic ionotropic drugs infusions or left ventricular assist device
Beschrijving

End stage cardiac failure | Inotropic agent Infusions chronic | Left ventricular assist device

Datatype

boolean

Alias
UMLS CUI [1]
C1868938
UMLS CUI [2,1]
C0304509
UMLS CUI [2,2]
C0574032
UMLS CUI [2,3]
C0205191
UMLS CUI [3]
C0181598
7. waiting on the transplant list as an unos status 1a or 1b patient
Beschrijving

On transplant waiting list | UNOS Status

Datatype

boolean

Alias
UMLS CUI [1]
C3484394
UMLS CUI [2,1]
C3826868
UMLS CUI [2,2]
C0449438
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Similar models

Eligibility Heart Failure NCT01357408

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Pregnancy Absent | Breast Feeding Absent
Item
1. men and non-pregnant/non lactating women ≥ 18 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hospital admission Heart failure Worsening
Item
2. admission to hospital or observation unit for worsening heart failure.
boolean
C0184666 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0332271 (UMLS CUI [1,3])
Heart Rate Monitoring System Specified | Indication Device implant
Item
3. has a reveal xt device or has plans for a device implant for a clinical indication within 14 days of discharge.
boolean
C4287153 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0948629 (UMLS CUI [2,2])
Cardiac ejection fraction Echocardiography
Item
4. ejection fraction ≥40% by echocardiogram within 6 months of enrollment
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Participation Clinical Trial Duration
Item
5. able to participate in the study for at least 6 months.
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Absence Enrollment Clinical Trial Other
Item
6. not currently enrolled in another study.
boolean
C0332197 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Informed Consent | Clinical Trial Visits Completion
Item
7. able to provide informed consent and complete scheduled study visits.
boolean
C0021430 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Indication Cardiac implant device | Indication Pacemaker | Indication Defibrillator
Item
1. has a clinical indication for a therapeutic cardiac device (pacemaker or defibrillator)
boolean
C3146298 (UMLS CUI [1,1])
C0581396 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0030163 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0180307 (UMLS CUI [3,2])
Permanent atrial fibrillation | Atrial Flutter Permanent
Item
2. history of permanent atrial fibrillation or atrial flutter.
boolean
C2586056 (UMLS CUI [1])
C0004239 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
Uncontrolled hypertension
Item
3. history of uncontrolled hypertension (high blood pressure)
boolean
C1868885 (UMLS CUI [1])
Cardiac implant device Previous | Pacemaker Previous | Defibrillator Previous
Item
4. has a previously implanted cardiac device (pacemaker or defibrillator) in place.
boolean
C0581396 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0180307 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Renal dysfunction chronic Stage | Estimated Glomerular Filtration Rate
Item
5. stage iv or v chronic renal dysfunction (estimated gfr <25 ml/min per 1.73 m2)
boolean
C3279454 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1306673 (UMLS CUI [1,3])
C3811844 (UMLS CUI [2])
End stage cardiac failure | Inotropic agent Infusions chronic | Left ventricular assist device
Item
6. end-stage (stage d) hf, including chronic ionotropic drugs infusions or left ventricular assist device
boolean
C1868938 (UMLS CUI [1])
C0304509 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0181598 (UMLS CUI [3])
On transplant waiting list | UNOS Status
Item
7. waiting on the transplant list as an unos status 1a or 1b patient
boolean
C3484394 (UMLS CUI [1])
C3826868 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
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