ID

39453

Beschreibung

Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack; ODM derived from: https://clinicaltrials.gov/show/NCT01438086

Link

https://clinicaltrials.gov/show/NCT01438086

Stichworte

Versionen (1)
  1. 11.01.20 11.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01438086

Englisch

Eligibility Heart Failure NCT01438086

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 - 75
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
presents within 2-12 hours of at least 30 minutes of myocardial ischemic pain
Beschreibung

ischemic pain Myocardial Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0745417
UMLS CUI [1,2]
C1522564
UMLS CUI [1,3]
C0449238
ecg evidence of myocardial infarction
Beschreibung

ECG Myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428953
undergoing percutaneous coronary intervention (pci) for st-elevation myocardial infarction
Beschreibung

Percutaneous Coronary Intervention ST segment elevation myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1536220
left ventricular ejection fraction during pci of 40% or less
Beschreibung

Left ventricular ejection fraction During Percutaneous Coronary Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1532338
timi flow grade 3 in the infarct-related artery following reperfusion and stenting
Beschreibung

TIMI Flow Grade | Artery Infarct Related | Status post Reperfusion | Status post Stenting

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3272266
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0003842
UMLS CUI [2,2]
C0021308
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0035124
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C2348535
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of prior myocardial infarction
Beschreibung

History of myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C1275835
prior history of heart failure, left ventricular dysfunction or cardiomyopathy
Beschreibung

History of heart failure | Left Ventricular Dysfunction Previous | History of cardiomyopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0455531
UMLS CUI [2,1]
C0242698
UMLS CUI [2,2]
C0205156
UMLS CUI [3]
C4039015
active or suspected neoplasia
Beschreibung

Neoplastic disease | Neoplastic disease Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2,1]
C1882062
UMLS CUI [2,2]
C0750491
known impaired liver function
Beschreibung

Liver Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
cardiogenic shock
Beschreibung

Shock, Cardiogenic

Datentyp

boolean

Alias
UMLS CUI [1]
C0036980
estimated glomerular filtration rate < 45 ml/min/1.73m2
Beschreibung

Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C3811844
history of hypoglycaemia requiring hospitalisation
Beschreibung

Hypoglycemia Hospitalization Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C1708385
history of primary insulin-like growth factor-1 deficiency or growth hormone disorders
Beschreibung

Primary insulin like growth factor-1 deficiency | Disorder of human growth hormone

Datentyp

boolean

Alias
UMLS CUI [1]
C3160868
UMLS CUI [2]
C1295597
contraindication to cardiac magnetic resonance imaging
Beschreibung

Medical contraindication Magnetic Resonance Imaging of Heart

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0412692
pregnancy or nursing mothers
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known allergy to study drug or any of its inactive ingredients
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Inactive ingredient

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]
C1552019
treatment with another investigational agent within 30 days of enrolment
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
subjects unable or unwilling to comply with follow-up requirements of study
Beschreibung

Compliance behavior Unable Follow-up | Compliance behavior Unwilling Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C3274571
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0558080
UMLS CUI [2,3]
C3274571
subjects unable to provide written informed consent
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Ähnliche Modelle

Eligibility Heart Failure NCT01438086

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 - 75
boolean
C0001779 (UMLS CUI [1])
ischemic pain Myocardial Duration
Item
presents within 2-12 hours of at least 30 minutes of myocardial ischemic pain
boolean
C0745417 (UMLS CUI [1,1])
C1522564 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
ECG Myocardial infarction
Item
ecg evidence of myocardial infarction
boolean
C0428953 (UMLS CUI [1])
Percutaneous Coronary Intervention ST segment elevation myocardial infarction
Item
undergoing percutaneous coronary intervention (pci) for st-elevation myocardial infarction
boolean
C1532338 (UMLS CUI [1,1])
C1536220 (UMLS CUI [1,2])
Left ventricular ejection fraction During Percutaneous Coronary Intervention
Item
left ventricular ejection fraction during pci of 40% or less
boolean
C0428772 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
TIMI Flow Grade | Artery Infarct Related | Status post Reperfusion | Status post Stenting
Item
timi flow grade 3 in the infarct-related artery following reperfusion and stenting
boolean
C3272266 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0003842 (UMLS CUI [2,1])
C0021308 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0035124 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C2348535 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
History of myocardial infarction
Item
history of prior myocardial infarction
boolean
C1275835 (UMLS CUI [1])
History of heart failure | Left Ventricular Dysfunction Previous | History of cardiomyopathy
Item
prior history of heart failure, left ventricular dysfunction or cardiomyopathy
boolean
C0455531 (UMLS CUI [1])
C0242698 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C4039015 (UMLS CUI [3])
Neoplastic disease | Neoplastic disease Suspected
Item
active or suspected neoplasia
boolean
C1882062 (UMLS CUI [1])
C1882062 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Liver Dysfunction
Item
known impaired liver function
boolean
C0086565 (UMLS CUI [1])
Shock, Cardiogenic
Item
cardiogenic shock
boolean
C0036980 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate < 45 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Hypoglycemia Hospitalization Required
Item
history of hypoglycaemia requiring hospitalisation
boolean
C0020615 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Primary insulin like growth factor-1 deficiency | Disorder of human growth hormone
Item
history of primary insulin-like growth factor-1 deficiency or growth hormone disorders
boolean
C3160868 (UMLS CUI [1])
C1295597 (UMLS CUI [2])
Medical contraindication Magnetic Resonance Imaging of Heart
Item
contraindication to cardiac magnetic resonance imaging
boolean
C1301624 (UMLS CUI [1,1])
C0412692 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Inactive ingredient
Item
known allergy to study drug or any of its inactive ingredients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
Investigational New Drugs
Item
treatment with another investigational agent within 30 days of enrolment
boolean
C0013230 (UMLS CUI [1])
Compliance behavior Unable Follow-up | Compliance behavior Unwilling Follow-up
Item
subjects unable or unwilling to comply with follow-up requirements of study
boolean
C1321605 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Informed Consent Unable
Item
subjects unable to provide written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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