ID

11718

Beskrivning

The objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, Troponin I, in an intended use population. Blood specimens will be tested using the new investigational test that detects the level of Troponin I. Results will be compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred. https://clinicaltrials.gov/ct2/show/NCT01608100

Länk

https://clinicaltrials.gov/ct2/show/NCT01608100

Nyckelord

Versioner (1)
  1. 2015-07-28 2015-07-28 -
Uppladdad den

28 juli 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cardiac Biomarker Assay Acute Coronary Syndrome NCT01608100

Engelsk

Eligibility Criteria

1 Formulär  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Beskrivning

Inclusion Criteria

presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.
Beskrivning

presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.

Datatyp

boolean

Alias
UMLS CUI-1
C0948089
an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS).
Beskrivning

an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS).

Datatyp

boolean

Alias
UMLS CUI-1
C0948089
greater than 18 years of age.
Beskrivning

greater than 18 years of age.

Datatyp

boolean

Alias
UMLS CUI-1
C0001779
not known to be pregnant.
Beskrivning

not known to be pregnant.

Datatyp

boolean

Alias
UMLS CUI-1
C0549206
Exclusion Criteria
Beskrivning

Exclusion Criteria

prior participation in this study.
Beskrivning

prior participation in this study.

Datatyp

boolean

Alias
UMLS CUI-1
C0422740
require dialysis for end stage renal disease.
Beskrivning

require dialysis for end stage renal disease.

Datatyp

boolean

Alias
UMLS CUI-1
C0019004
require dialysis for end stage renal disease.
Beskrivning

require dialysis for end stage renal disease.

Datatyp

boolean

Alias
UMLS CUI-1
C0035078
history of a previous heart transplant.
Beskrivning

history of a previous heart transplant.

Datatyp

boolean

Alias
UMLS CUI-1
C0018823
coexisting disorder associated with limited life expectancy.
Beskrivning

coexisting disorder associated with limited life expectancy.

Datatyp

boolean

Alias
UMLS CUI-1
C0679247
currently participating in another investigational device or drug study.
Beskrivning

currently participating in another investigational device or drug study.

Datatyp

boolean

Alias
UMLS CUI-1
C0422740
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Similar models

Eligibility Criteria

1 Formulär
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
Acute coronary syndrome
Item
presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.
boolean
C0948089 (UMLS CUI-1)
Acute coronary syndrome
Item
an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS).
boolean
C0948089 (UMLS CUI-1)
Age
Item
greater than 18 years of age.
boolean
C0001779 (UMLS CUI-1)
Pregnancy
Item
not known to be pregnant.
boolean
C0549206 (UMLS CUI-1)
Item Group
Exclusion Criteria
Study patient
Item
prior participation in this study.
boolean
C0422740 (UMLS CUI-1)
Hemodialysis
Item
require dialysis for end stage renal disease.
boolean
C0019004 (UMLS CUI-1)
Kidney failure
Item
require dialysis for end stage renal disease.
boolean
C0035078 (UMLS CUI-1)
Heart transplant
Item
history of a previous heart transplant.
boolean
C0018823 (UMLS CUI-1)
Terminal illness
Item
coexisting disorder associated with limited life expectancy.
boolean
C0679247 (UMLS CUI-1)
Study patient
Item
currently participating in another investigational device or drug study.
boolean
C0422740 (UMLS CUI-1)
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