ID

37471

Beschreibung

Anticoagulation in Stent Intervention; ODM derived from: https://clinicaltrials.gov/show/NCT01141153

Link

https://clinicaltrials.gov/show/NCT01141153

Stichworte

Versionen (1)
  1. 30.07.19 30.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

30. Juli 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01141153

Englisch

Eligibility Atrial Fibrillation NCT01141153

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients of both sexes older than 18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with permanent atrial fibrillation, persistent or paroxysmal (at least one episode), documented electrocardiographically and receiving oral anticoagulation. patients with acute coronary syndrome or stable angina who are undergoing pci-s.
Beschreibung

Permanent atrial fibrillation Electrocardiography | Persistent atrial fibrillation Electrocardiography | Paroxysmal atrial fibrillation Episode Quantity Electrocardiography | Anticoagulation Therapy Oral | Acute Coronary Syndrome | Stable angina | Percutaneous Coronary Intervention with Stent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2586056
UMLS CUI [1,2]
C1623258
UMLS CUI [2,1]
C2585653
UMLS CUI [2,2]
C1623258
UMLS CUI [3,1]
C0235480
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C1623258
UMLS CUI [4,1]
C0003281
UMLS CUI [4,2]
C1527415
UMLS CUI [5]
C0948089
UMLS CUI [6]
C0340288
UMLS CUI [7,1]
C1532338
UMLS CUI [7,2]
C0332287
UMLS CUI [7,3]
C0038257
patients who have previously given their informed consent to participation in the study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who can not be followed by the research team during the 12 months provided for monitoring.
Beschreibung

Follow-up Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1272705
patients with renal failure or serum creatinine above 2 mg • dl-1, neurological deficits, active ulcer or epigastric pain.
Beschreibung

Kidney Failure | Creatinine measurement, serum | Neurologic Deficits | Ulcer | Epigastric pain

Datentyp

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0521654
UMLS CUI [4]
C0041582
UMLS CUI [5]
C0232493
patients who continue regular treatment with nsaids or other analgesics or corticosteroids.
Beschreibung

NSAIDs Regular | Analgesics Regular | Adrenal Cortex Hormones Regular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0002771
UMLS CUI [2,2]
C0205272
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205272
patients undergoing reoperation.
Beschreibung

Reoperation

Datentyp

boolean

Alias
UMLS CUI [1]
C0035110
patients who during the study period, should receive, according to medical criteria, other adjuvant drug treatment than that specified in this protocol.
Beschreibung

Pharmacotherapy Adjuvant | Exception Pharmacotherapy Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1522673
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C2348563
pregnant women.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
use of investigational agents or not registered within 30 days of entry into the study.
Beschreibung

Investigational New Drugs | Drugs, Non-Prescription

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
patients with a history of allergy to study drugs or excipients.
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipients

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
patients with severe valve disease.
Beschreibung

Valvular disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0205082
patients with chads> 2.
Beschreibung

CHADS2 score

Datentyp

boolean

Alias
UMLS CUI [1]
C2585876
patients who can not use the study drug orally.
Beschreibung

Lacking Able to swallow Investigational New Drugs Oral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C1527415
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT01141153

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients of both sexes older than 18 years.
boolean
C0001779 (UMLS CUI [1])
Permanent atrial fibrillation Electrocardiography | Persistent atrial fibrillation Electrocardiography | Paroxysmal atrial fibrillation Episode Quantity Electrocardiography | Anticoagulation Therapy Oral | Acute Coronary Syndrome | Stable angina | Percutaneous Coronary Intervention with Stent
Item
patients with permanent atrial fibrillation, persistent or paroxysmal (at least one episode), documented electrocardiographically and receiving oral anticoagulation. patients with acute coronary syndrome or stable angina who are undergoing pci-s.
boolean
C2586056 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C2585653 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
C0235480 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C1623258 (UMLS CUI [3,4])
C0003281 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0948089 (UMLS CUI [5])
C0340288 (UMLS CUI [6])
C1532338 (UMLS CUI [7,1])
C0332287 (UMLS CUI [7,2])
C0038257 (UMLS CUI [7,3])
Informed Consent
Item
patients who have previously given their informed consent to participation in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Follow-up Unsuccessful
Item
patients who can not be followed by the research team during the 12 months provided for monitoring.
boolean
C3274571 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Kidney Failure | Creatinine measurement, serum | Neurologic Deficits | Ulcer | Epigastric pain
Item
patients with renal failure or serum creatinine above 2 mg • dl-1, neurological deficits, active ulcer or epigastric pain.
boolean
C0035078 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0521654 (UMLS CUI [3])
C0041582 (UMLS CUI [4])
C0232493 (UMLS CUI [5])
NSAIDs Regular | Analgesics Regular | Adrenal Cortex Hormones Regular
Item
patients who continue regular treatment with nsaids or other analgesics or corticosteroids.
boolean
C0003211 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0002771 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
Reoperation
Item
patients undergoing reoperation.
boolean
C0035110 (UMLS CUI [1])
Pharmacotherapy Adjuvant | Exception Pharmacotherapy Study Protocol
Item
patients who during the study period, should receive, according to medical criteria, other adjuvant drug treatment than that specified in this protocol.
boolean
C0013216 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Pregnancy
Item
pregnant women.
boolean
C0032961 (UMLS CUI [1])
Investigational New Drugs | Drugs, Non-Prescription
Item
use of investigational agents or not registered within 30 days of entry into the study.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipients
Item
patients with a history of allergy to study drugs or excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Valvular disease Severe
Item
patients with severe valve disease.
boolean
C3258293 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
CHADS2 score
Item
patients with chads> 2.
boolean
C2585876 (UMLS CUI [1])
Lacking Able to swallow Investigational New Drugs Oral
Item
patients who can not use the study drug orally.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1527415 (UMLS CUI [1,4])
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