ID

34819

Descrizione

Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older; ODM derived from: https://clinicaltrials.gov/show/NCT02392754

collegamento

https://clinicaltrials.gov/show/NCT02392754

Keywords

versioni (1)
  1. 30/01/19 30/01/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

30 gennaio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02392754

Inglese

Eligibility Atrial Fibrillation NCT02392754

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥75 years without known atrial fibrillation or atrial flutter.
Descrizione

Age | Atrial Fibrillation Absent | Atrial Flutter Absent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0004239
UMLS CUI [3,2]
C0332197
2. the participant is clinically in sinus rhythm (both heart auscultation and 30- second pulse palpation have been performed by the enrolling physician and neither detects an irregular rhythm suggestive of atrial fibrillation).
Descrizione

Sinus rhythm | Heart Auscultation | Finding of pulse taking by palpation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232201
UMLS CUI [2]
C0018793
UMLS CUI [3]
C1720373
3. history of hypertension requiring antihypertensive medication.
Descrizione

Hypertensive disease Requiring Antihypertensive Agents

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003364
4. written informed consent from the participant.
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any previously documented atrial fibrillation or atrial flutter ≥30 seconds.
Descrizione

Atrial Fibrillation Previous Seconds Quantity | Atrial Flutter Previous Seconds Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0457385
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0004239
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0457385
UMLS CUI [2,4]
C1265611
2. implanted pacemaker, cardiac defibrillator, cardiac loop recorder, or deep brain stimulator.
Descrizione

Pacemaker implant | Presence of cardiac defibrillator | Implantable loop recorder present | Deep brain stimulator implant

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0848753
UMLS CUI [2]
C1391956
UMLS CUI [3]
C3838353
UMLS CUI [4]
C4069029
3. likely to be poorly compliant or unreliable using home screening devices or with study follow-up requirements because of cognitive or other issues, or life expectancy <6 months due to concomitant disease.
Descrizione

Protocol Compliance Poor | Impaired cognition | Life Expectancy Due to Comorbidity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0338656
UMLS CUI [3,1]
C0023671
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0009488
4. has a condition which in the opinion of the enrolling physician would not permit chronic treatment with oral anticoagulant therapy.
Descrizione

Condition Preventing Anticoagulant therapy Oral

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0150457
UMLS CUI [1,4]
C1527415
5. patient already taking long-term oral anticoagulant therapy.
Descrizione

Anticoagulant therapy Oral Long-term

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0443252
6. known allergic reaction/intolerance to skin adhesives.
Descrizione

Allergic Reaction Skin tissue adhesive | Intolerance to Skin tissue adhesive

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1714038
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1714038
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Similar models

Eligibility Atrial Fibrillation NCT02392754

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age | Atrial Fibrillation Absent | Atrial Flutter Absent
Item
1. age ≥75 years without known atrial fibrillation or atrial flutter.
boolean
C0001779 (UMLS CUI [1])
C0004238 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0004239 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Sinus rhythm | Heart Auscultation | Finding of pulse taking by palpation
Item
2. the participant is clinically in sinus rhythm (both heart auscultation and 30- second pulse palpation have been performed by the enrolling physician and neither detects an irregular rhythm suggestive of atrial fibrillation).
boolean
C0232201 (UMLS CUI [1])
C0018793 (UMLS CUI [2])
C1720373 (UMLS CUI [3])
Hypertensive disease Requiring Antihypertensive Agents
Item
3. history of hypertension requiring antihypertensive medication.
boolean
C0020538 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003364 (UMLS CUI [1,3])
Informed Consent
Item
4. written informed consent from the participant.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Previous Seconds Quantity | Atrial Flutter Previous Seconds Quantity
Item
1. any previously documented atrial fibrillation or atrial flutter ≥30 seconds.
boolean
C0004238 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0457385 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0004239 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0457385 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Pacemaker implant | Presence of cardiac defibrillator | Implantable loop recorder present | Deep brain stimulator implant
Item
2. implanted pacemaker, cardiac defibrillator, cardiac loop recorder, or deep brain stimulator.
boolean
C0848753 (UMLS CUI [1])
C1391956 (UMLS CUI [2])
C3838353 (UMLS CUI [3])
C4069029 (UMLS CUI [4])
Protocol Compliance Poor | Impaired cognition | Life Expectancy Due to Comorbidity
Item
3. likely to be poorly compliant or unreliable using home screening devices or with study follow-up requirements because of cognitive or other issues, or life expectancy <6 months due to concomitant disease.
boolean
C0525058 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0338656 (UMLS CUI [2])
C0023671 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0009488 (UMLS CUI [3,3])
Condition Preventing Anticoagulant therapy Oral
Item
4. has a condition which in the opinion of the enrolling physician would not permit chronic treatment with oral anticoagulant therapy.
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0150457 (UMLS CUI [1,3])
C1527415 (UMLS CUI [1,4])
Anticoagulant therapy Oral Long-term
Item
5. patient already taking long-term oral anticoagulant therapy.
boolean
C0150457 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Allergic Reaction Skin tissue adhesive | Intolerance to Skin tissue adhesive
Item
6. known allergic reaction/intolerance to skin adhesives.
boolean
C1527304 (UMLS CUI [1,1])
C1714038 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1714038 (UMLS CUI [2,2])
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