ID

15377

Beschrijving

MetfoRmin and Its Effects on Left Ventricular Hypertrophy in Normotensive Patients With Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02226510

Link

https://clinicaltrials.gov/show/NCT02226510

Trefwoorden

Versies (1)
  1. 28-05-16 28-05-16 -
Geüploaded op

28 mei 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Left Ventricular Hypertrophy NCT02226510

Engels

Eligibility Left Ventricular Hypertrophy NCT02226510

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18 years or over
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
participant willing and able to give informed consent.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
documented ischaemic heart disease: either angio-graphically documented coronary artery disease or a previous history of myocardial infarction/angina.
Beschrijving

Ischaemic heart disease | Coronary heart disease angiogram | History of myocardial infarction | H/O: angina pectoris

Datatype

boolean

Alias
UMLS CUI [1]
C1869045
UMLS CUI [2,1]
C0010068
UMLS CUI [2,2]
C0002978
UMLS CUI [3]
C1275835
UMLS CUI [4]
C0455530
screening echocardiography based diagnosis of lvh based on ase criteria (males >115g/m2, females >95g/m2)
Beschrijving

Left Ventricular Hypertrophy Echocardiography | Gender

Datatype

boolean

Alias
UMLS CUI [1,1]
C0149721
UMLS CUI [1,2]
C0013516
UMLS CUI [2]
C0079399
fasting insulin resistance index ≥ 2.7 and/or hba1c >5.6 and less than 6.5 at screening
Beschrijving

Fasting insulin measurement Resistance.index | Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1,1]
C2016107
UMLS CUI [1,2]
C0807745
UMLS CUI [2]
C0019018
blood pressure < 140/85 mm hg or 24hr bp <135/85 daytime average in screening
Beschrijving

Blood Pressure | 24 hour blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0005823
UMLS CUI [2]
C1282173
able (in the investigators opinion) and willing to comply with all study requirements.
Beschrijving

Compliance behavior Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
cognitive impairment
Beschrijving

Impaired cognition

Datatype

boolean

Alias
UMLS CUI [1]
C0338656
type 1 or 2 diabetes mellitus
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
chronic heart failure as evidenced by echocardiogram or documented diagnosis of chf
Beschrijving

Chronic heart failure Echocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0013516
left ventricular ejection fraction <45% on screening echocardiography
Beschrijving

Left ventricular ejection fraction Echocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
contraindications to cardiac mri (pacemakers, claustrophobia, metal implants, history of penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
Beschrijving

Medical contraindication Magnetic Resonance Imaging (MRI) of Heart | Artificial cardiac pacemaker | Claustrophobia | Presence of metallic device / implant | Eye Injuries, Penetrating | Eye Exposure to Retained metal fragments

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0412692
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0008909
UMLS CUI [4]
C3693688
UMLS CUI [5]
C0015409
UMLS CUI [6,1]
C0015392
UMLS CUI [6,2]
C0332157
UMLS CUI [6,3]
C2921327
malignancy (receiving active treatment) or other life threatening disease, renal disease (ckd class 3b or worse)
Beschrijving

Malignant Neoplasms Therapeutic procedure | Life-threatening disease | Kidney Diseases | Chronic Kidney Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C3553594
UMLS CUI [3]
C0022658
UMLS CUI [4]
C1561643
pregnancy/lactating females
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any other reason considered inappropriate by a study physician
Beschrijving

Indication of Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1548788
participants who have participated in any other clinical trial within the previous 30 days.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Left Ventricular Hypertrophy NCT02226510

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 18 years or over
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
participant willing and able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Ischaemic heart disease | Coronary heart disease angiogram | History of myocardial infarction | H/O: angina pectoris
Item
documented ischaemic heart disease: either angio-graphically documented coronary artery disease or a previous history of myocardial infarction/angina.
boolean
C1869045 (UMLS CUI [1])
C0010068 (UMLS CUI [2,1])
C0002978 (UMLS CUI [2,2])
C1275835 (UMLS CUI [3])
C0455530 (UMLS CUI [4])
Left Ventricular Hypertrophy Echocardiography | Gender
Item
screening echocardiography based diagnosis of lvh based on ase criteria (males >115g/m2, females >95g/m2)
boolean
C0149721 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
Fasting insulin measurement Resistance.index | Glycosylated hemoglobin A
Item
fasting insulin resistance index ≥ 2.7 and/or hba1c >5.6 and less than 6.5 at screening
boolean
C2016107 (UMLS CUI [1,1])
C0807745 (UMLS CUI [1,2])
C0019018 (UMLS CUI [2])
Blood Pressure | 24 hour blood pressure
Item
blood pressure < 140/85 mm hg or 24hr bp <135/85 daytime average in screening
boolean
C0005823 (UMLS CUI [1])
C1282173 (UMLS CUI [2])
Compliance behavior Study Protocol
Item
able (in the investigators opinion) and willing to comply with all study requirements.
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Impaired cognition
Item
cognitive impairment
boolean
C0338656 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
type 1 or 2 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Chronic heart failure Echocardiography
Item
chronic heart failure as evidenced by echocardiogram or documented diagnosis of chf
boolean
C0264716 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Left ventricular ejection fraction Echocardiography
Item
left ventricular ejection fraction <45% on screening echocardiography
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Medical contraindication Magnetic Resonance Imaging (MRI) of Heart | Artificial cardiac pacemaker | Claustrophobia | Presence of metallic device / implant | Eye Injuries, Penetrating | Eye Exposure to Retained metal fragments
Item
contraindications to cardiac mri (pacemakers, claustrophobia, metal implants, history of penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
boolean
C1301624 (UMLS CUI [1,1])
C0412692 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0008909 (UMLS CUI [3])
C3693688 (UMLS CUI [4])
C0015409 (UMLS CUI [5])
C0015392 (UMLS CUI [6,1])
C0332157 (UMLS CUI [6,2])
C2921327 (UMLS CUI [6,3])
Malignant Neoplasms Therapeutic procedure | Life-threatening disease | Kidney Diseases | Chronic Kidney Diseases
Item
malignancy (receiving active treatment) or other life threatening disease, renal disease (ckd class 3b or worse)
boolean
C0006826 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3553594 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C1561643 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnancy/lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Indication of Inappropriate
Item
any other reason considered inappropriate by a study physician
boolean
C0392360 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participants who have participated in any other clinical trial within the previous 30 days.
boolean
C2348568 (UMLS CUI [1])
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