ID

11718

Description

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

Keywords

Versions (1)
  1. 7/28/15 7/28/15 -
Uploaded on

July 28, 2015

DOI

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License

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

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Description

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.
Description

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.

Data type

boolean

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

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

Data type

boolean

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

greater than 18 years of age.

Data type

boolean

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

not known to be pregnant.

Data type

boolean

Alias
UMLS CUI-1
C0549206
Exclusion Criteria
Description

Exclusion Criteria

prior participation in this study.
Description

prior participation in this study.

Data type

boolean

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

require dialysis for end stage renal disease.

Data type

boolean

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

require dialysis for end stage renal disease.

Data type

boolean

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

history of a previous heart transplant.

Data type

boolean

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

coexisting disorder associated with limited life expectancy.

Data type

boolean

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

currently participating in another investigational device or drug study.

Data type

boolean

Alias
UMLS CUI-1
C0422740
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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