ID

11718

Beschreibung

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

Link

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

Stichworte

Versionen (1)
  1. 28.07.15 28.07.15 -
Hochgeladen am

28. Juli 2015

DOI

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Lizenz

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

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Beschreibung

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.
Beschreibung

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.

Datentyp

boolean

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

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

Datentyp

boolean

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

greater than 18 years of age.

Datentyp

boolean

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

not known to be pregnant.

Datentyp

boolean

Alias
UMLS CUI-1
C0549206
Exclusion Criteria
Beschreibung

Exclusion Criteria

prior participation in this study.
Beschreibung

prior participation in this study.

Datentyp

boolean

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

require dialysis for end stage renal disease.

Datentyp

boolean

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

require dialysis for end stage renal disease.

Datentyp

boolean

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

history of a previous heart transplant.

Datentyp

boolean

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

coexisting disorder associated with limited life expectancy.

Datentyp

boolean

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

currently participating in another investigational device or drug study.

Datentyp

boolean

Alias
UMLS CUI-1
C0422740
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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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