ID

43655

Description

Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00126074

Link

https://clinicaltrials.gov/show/NCT00126074

Keywords

  1. 4/23/16 4/23/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT00126074

Eligibility Atrial Fibrillation NCT00126074

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing to sign informed consent before screening examinations are performed and before the study drug is administered
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
females > 18 years of age
Description

Female Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C0001779
subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration > 3 hours and < 45 days) at the time of randomization
Description

ATRIAL FIBRILLATION SYMPTOMATIC | Atrial Flutter | Randomization

Data type

boolean

Alias
UMLS CUI [1]
C0741283
UMLS CUI [2]
C0004239
UMLS CUI [3]
C0034656
subjects who are in no distress and hemodynamically stable (supine systolic blood pressure > 90 mmhg and diastolic blood pressure < 105 mmhg)
Description

Distress | Hemodynamically stable | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0231303
UMLS CUI [2]
C0578150
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy and lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
acute myocardial infarction and cerebrovascular accidents
Description

Acute myocardial infarction | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0155626
UMLS CUI [2]
C0038454
coronary syndromes and congestive heart failure (chf) new york heart association (nyha) iv
Description

Acute Coronary Syndrome | Congestive heart failure New York Heart Association Class IV

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1882087
life-threatening ventricular arrhythmias and electrocardiogram (ecg) abnormalities
Description

Life Threatening Ventricular arrhythmia | Electrocardiogram abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C2826244
UMLS CUI [1,2]
C0085612
UMLS CUI [2]
C0522055
concurrent antiarrhythmic treatments
Description

Therapeutic procedure Anti-Arrhythmia Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003195

Similar models

Eligibility Atrial Fibrillation NCT00126074

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
willing to sign informed consent before screening examinations are performed and before the study drug is administered
boolean
C0021430 (UMLS CUI [1])
Female Age
Item
females > 18 years of age
boolean
C0086287 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
ATRIAL FIBRILLATION SYMPTOMATIC | Atrial Flutter | Randomization
Item
subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration > 3 hours and < 45 days) at the time of randomization
boolean
C0741283 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
C0034656 (UMLS CUI [3])
Distress | Hemodynamically stable | Systolic Pressure | Diastolic blood pressure
Item
subjects who are in no distress and hemodynamically stable (supine systolic blood pressure > 90 mmhg and diastolic blood pressure < 105 mmhg)
boolean
C0231303 (UMLS CUI [1])
C0578150 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy and lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Acute myocardial infarction | Cerebrovascular accident
Item
acute myocardial infarction and cerebrovascular accidents
boolean
C0155626 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Acute Coronary Syndrome | Congestive heart failure New York Heart Association Class IV
Item
coronary syndromes and congestive heart failure (chf) new york heart association (nyha) iv
boolean
C0948089 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1882087 (UMLS CUI [2,2])
Life Threatening Ventricular arrhythmia | Electrocardiogram abnormal
Item
life-threatening ventricular arrhythmias and electrocardiogram (ecg) abnormalities
boolean
C2826244 (UMLS CUI [1,1])
C0085612 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2])
Therapeutic procedure Anti-Arrhythmia Agents
Item
concurrent antiarrhythmic treatments
boolean
C0087111 (UMLS CUI [1,1])
C0003195 (UMLS CUI [1,2])

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