ID

37602

Beschreibung

Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis; ODM derived from: https://clinicaltrials.gov/show/NCT02073396

Link

https://clinicaltrials.gov/show/NCT02073396

Stichworte

Versionen (1)
  1. 10.08.19 10.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. August 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02073396

Englisch

Eligibility Atrial Fibrillation NCT02073396

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female participants aged 18 years or over.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients diagnosed with cad or af and free of exclusion criteria below.
Beschreibung

Coronary Artery Disease | Atrial Fibrillation | Free of Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0004238
UMLS CUI [3,1]
C0332296
UMLS CUI [3,2]
C0680251
3. not actively using tobacco products (due to vasoactive and pro-aggregatory effects of nicotine).
Beschreibung

Tobacco use Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0332197
4. the participant is willing and able to understand the subject information sheet and provide informed consent.
Beschreibung

Comprehension Informed Consent | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0021430
UMLS CUI [2]
C0021430
5. the participant must agree to comply with the drawing of blood samples for the assessments.
Beschreibung

Agreement Blood samples taking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0190979
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. male and female participants aged < 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with impaired renal function egfr <30 ml/min (since renal failure is associated with platelet function defect that may confound results).
Beschreibung

Renal Insufficiency | Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
3. the participant has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haemorrhagic metabolic or other disease likely to confound the study requirements or analyses.
Beschreibung

Nervous system disorder | Liver disease | Kidney Disease | Endocrine System Diseases | Cardiovascular Disease | Gastrointestinal Disease | Lung disease | Hemorrhagic Disorder | Metabolic Disease | Disease Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0014130
UMLS CUI [5]
C0007222
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0024115
UMLS CUI [8]
C0019087
UMLS CUI [9]
C0025517
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0525058
4. the participant has a gives a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease.
Beschreibung

Substance Use Disorders | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
5. alcohol consumption above recommended safe levels (i.e. more than 21 units per week for males, or more than 14 units per week for females) due to the potential effects of high alcohol levels on platelet reactivity.
Beschreibung

Alcohol intake above recommended sensible limits | Alcohol units/week | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0560219
UMLS CUI [2]
C0560579
UMLS CUI [3]
C0079399
6. any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study.
Beschreibung

Illness Significant Recently

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332185
7. any major bleeding diathesis or blood dyscrasia (platelets < 70 x 109/l, hb <8 g/dl, inr>1.4, aptt> x 2unl, leucocyte count< 3.5x 109/l, neutrophil count < 1x 109/l)
Beschreibung

Bleeding tendency Major | Hematological Disease | Platelet Count measurement | Hemoglobin measurement | International Normalized Ratio | Activated Partial Thromboplastin Time measurement | White Blood Cell Count procedure | Neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0018939
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0525032
UMLS CUI [6]
C0030605
UMLS CUI [7]
C0023508
UMLS CUI [8]
C0200633
8. currently enrolled in an investigational device or drug trial.
Beschreibung

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT02073396

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male and female participants aged 18 years or over.
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease | Atrial Fibrillation | Free of Exclusion Criteria
Item
2. patients diagnosed with cad or af and free of exclusion criteria below.
boolean
C1956346 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
C0332296 (UMLS CUI [3,1])
C0680251 (UMLS CUI [3,2])
Tobacco use Absent
Item
3. not actively using tobacco products (due to vasoactive and pro-aggregatory effects of nicotine).
boolean
C0543414 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Comprehension Informed Consent | Informed Consent
Item
4. the participant is willing and able to understand the subject information sheet and provide informed consent.
boolean
C0162340 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Agreement Blood samples taking
Item
5. the participant must agree to comply with the drawing of blood samples for the assessments.
boolean
C0680240 (UMLS CUI [1,1])
C0190979 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. male and female participants aged < 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
2. patients with impaired renal function egfr <30 ml/min (since renal failure is associated with platelet function defect that may confound results).
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Nervous system disorder | Liver disease | Kidney Disease | Endocrine System Diseases | Cardiovascular Disease | Gastrointestinal Disease | Lung disease | Hemorrhagic Disorder | Metabolic Disease | Disease Interferes with Protocol Compliance
Item
3. the participant has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haemorrhagic metabolic or other disease likely to confound the study requirements or analyses.
boolean
C0027765 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0007222 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
C0019087 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0012634 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0525058 (UMLS CUI [10,3])
Substance Use Disorders | Mental disorders
Item
4. the participant has a gives a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease.
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Alcohol intake above recommended sensible limits | Alcohol units/week | Gender
Item
5. alcohol consumption above recommended safe levels (i.e. more than 21 units per week for males, or more than 14 units per week for females) due to the potential effects of high alcohol levels on platelet reactivity.
boolean
C0560219 (UMLS CUI [1])
C0560579 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Illness Significant Recently
Item
6. any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study.
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Bleeding tendency Major | Hematological Disease | Platelet Count measurement | Hemoglobin measurement | International Normalized Ratio | Activated Partial Thromboplastin Time measurement | White Blood Cell Count procedure | Neutrophil count
Item
7. any major bleeding diathesis or blood dyscrasia (platelets < 70 x 109/l, hb <8 g/dl, inr>1.4, aptt> x 2unl, leucocyte count< 3.5x 109/l, neutrophil count < 1x 109/l)
boolean
C1458140 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0018939 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0525032 (UMLS CUI [5])
C0030605 (UMLS CUI [6])
C0023508 (UMLS CUI [7])
C0200633 (UMLS CUI [8])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
8. currently enrolled in an investigational device or drug trial.
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
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