ID

39382

Beskrivning

Cardiovascular and Neurohormonal Effects of Faster Atrial Pacing Rate; ODM derived from: https://clinicaltrials.gov/show/NCT00698139

Länk

https://clinicaltrials.gov/show/NCT00698139

Nyckelord

Versioner (1)
  1. 2020-01-05 2020-01-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 januari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00698139

Engelsk

Eligibility Heart Failure NCT00698139

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age>18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. congestive heart failure (chf) (>6 months duration)
Beskrivning

Congestive heart failure Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0449238
3. left ventricular ejection fraction (lvef) <40%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
4. functional class ii-iii
Beskrivning

New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
5. stable oral treatment (>1 month),
Beskrivning

Therapy Oral medication Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0175795
UMLS CUI [1,3]
C0205360
6. implanted medtronic pacemaker/defibrillator with a) an atrial pacing lead and biventricular leads, or b) an atrial pacing lead and a single ventricular lead in patients with a narrow (normal) qrs complex (<120 msec) thus with no clinical indication for biventricular pacing.
Beskrivning

Artificial cardiac pacemaker | Implantable defibrillator | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
UMLS CUI [3]
C3846158
7. low heart rate (hr) (sinus rhythm (sr) or atrial pacing <70 bpm)
Beskrivning

Bradycardia | Sinus rhythm | Atrial pacing pattern BPM

Datatyp

boolean

Alias
UMLS CUI [1]
C0428977
UMLS CUI [2]
C0232201
UMLS CUI [3,1]
C0429117
UMLS CUI [3,2]
C0439385
8. symptomatically stable (with no clinical requirement for adjustments in medical therapy, i.e. diuretics)
Beskrivning

Symptoms Stable | Requirement Absent Diuretics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0012798
9. increase in intrathoracic fluid as evidenced by rain natriuretic peptide (bnp) >200.
Beskrivning

Thoracic Fluid Increased | Brain natriuretic peptide measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4288132
UMLS CUI [1,2]
C0205217
UMLS CUI [2]
C1095989
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. atrial fibrillation
Beskrivning

Atrial Fibrillation

Datatyp

boolean

Alias
UMLS CUI [1]
C0004238
2. stable or unstable angina
Beskrivning

Stable angina | Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0340288
UMLS CUI [2]
C0002965
3. myocardial infarction within 6 months before the study
Beskrivning

Recent myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C1998297
4. intravenous inotropic support
Beskrivning

Inotropic agent Intravenous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C1522726
5. pregnant or breast feeding women. women of child bearing potential must have a negative serum pregnancy test prior to enrollment.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
6. severe renal failure (creatinine> 2.5 mg/dl, hemodyalisis or peritoneal dialysis)
Beskrivning

Kidney Failure Severe | Creatinine measurement, serum | Hemodialysis | Peritoneal Dialysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0019004
UMLS CUI [4]
C0031139
7. known hepatic impairment (total bilirubin >3 mg/dl, albumin <2.8 mg/dl, or increased ammonia levels if performed)
Beskrivning

Hepatic impairment | Serum total bilirubin measurement | Albumin measurement | Increased serum ammonia

Datatyp

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201838
UMLS CUI [4]
C0740942
8. hemoglobin (hgb) <8 mg %, or active bleeding requiring transfusion
Beskrivning

Hemoglobin measurement | Hemorrhage Requirement Transfusion

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1879316
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Similar models

Eligibility Heart Failure NCT00698139

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age>18
boolean
C0001779 (UMLS CUI [1])
Congestive heart failure Duration
Item
2. congestive heart failure (chf) (>6 months duration)
boolean
C0018802 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
3. left ventricular ejection fraction (lvef) <40%
boolean
C0428772 (UMLS CUI [1])
New York Heart Association Classification
Item
4. functional class ii-iii
boolean
C1275491 (UMLS CUI [1])
Therapy Oral medication Stable
Item
5. stable oral treatment (>1 month),
boolean
C0087111 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Artificial cardiac pacemaker | Implantable defibrillator | Other Coding
Item
6. implanted medtronic pacemaker/defibrillator with a) an atrial pacing lead and biventricular leads, or b) an atrial pacing lead and a single ventricular lead in patients with a narrow (normal) qrs complex (<120 msec) thus with no clinical indication for biventricular pacing.
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Bradycardia | Sinus rhythm | Atrial pacing pattern BPM
Item
7. low heart rate (hr) (sinus rhythm (sr) or atrial pacing <70 bpm)
boolean
C0428977 (UMLS CUI [1])
C0232201 (UMLS CUI [2])
C0429117 (UMLS CUI [3,1])
C0439385 (UMLS CUI [3,2])
Symptoms Stable | Requirement Absent Diuretics
Item
8. symptomatically stable (with no clinical requirement for adjustments in medical therapy, i.e. diuretics)
boolean
C1457887 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0012798 (UMLS CUI [2,3])
Thoracic Fluid Increased | Brain natriuretic peptide measurement
Item
9. increase in intrathoracic fluid as evidenced by rain natriuretic peptide (bnp) >200.
boolean
C4288132 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C1095989 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation
Item
1. atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Stable angina | Angina, Unstable
Item
2. stable or unstable angina
boolean
C0340288 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Recent myocardial infarction
Item
3. myocardial infarction within 6 months before the study
boolean
C1998297 (UMLS CUI [1])
Inotropic agent Intravenous
Item
4. intravenous inotropic support
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative
Item
5. pregnant or breast feeding women. women of child bearing potential must have a negative serum pregnancy test prior to enrollment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
Kidney Failure Severe | Creatinine measurement, serum | Hemodialysis | Peritoneal Dialysis
Item
6. severe renal failure (creatinine> 2.5 mg/dl, hemodyalisis or peritoneal dialysis)
boolean
C0035078 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C0019004 (UMLS CUI [3])
C0031139 (UMLS CUI [4])
Hepatic impairment | Serum total bilirubin measurement | Albumin measurement | Increased serum ammonia
Item
7. known hepatic impairment (total bilirubin >3 mg/dl, albumin <2.8 mg/dl, or increased ammonia levels if performed)
boolean
C0948807 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201838 (UMLS CUI [3])
C0740942 (UMLS CUI [4])
Hemoglobin measurement | Hemorrhage Requirement Transfusion
Item
8. hemoglobin (hgb) <8 mg %, or active bleeding requiring transfusion
boolean
C0518015 (UMLS CUI [1])
C0019080 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1879316 (UMLS CUI [2,3])
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