ID

35930

Descrição

Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02358603

Link

https://clinicaltrials.gov/show/NCT02358603

Palavras-chave

Versões (1)
  1. 04/04/2019 04/04/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de abril de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02358603

Inglês

Eligibility Heart Failure NCT02358603

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is greater than 18 years of age and less than 70 years of old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patient is willing and able to give informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patient has been diagnosed with stable chronic hf according to european society of cardiology 2012 hf guidance.
Descrição

Chronic heart failure Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C0205360
new york heart association class i- iii, including with hf with preserved ejection fraction and hf with reduced ejection fraction patients.
Descrição

New York Heart Association Classification | Heart failure with preserved ejection fraction [HFpEF] | Heart failure with reduced ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C4509226
UMLS CUI [3]
C3839346
patients can perform moderate exercise.
Descrição

Ability Moderate Exercise

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1513375
left ventricular ejection fraction less than 55% but greater than 35%.
Descrição

Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is unable or unwilling to sign the patient informed consent.
Descrição

infoInformed Consent Unable | Informed Consent Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
patient has implantable pacemaker, implantable cardiovert defibrillator (icd) or cardiac resynchronize therapy (crt) device.
Descrição

Artificial cardiac pacemaker | ICD | CRT Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
UMLS CUI [3]
C2936377
patient has at least one pacemaker, icd or crt indications.
Descrição

Indication Quantity Artificial cardiac pacemaker | Indication Quantity ICD | Indication Quantity CRT Device

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0030163
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0162589
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C2936377
patients has persistent atrial fibrillation (af).
Descrição

Persistent atrial fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2585653
patient whose hear rate baseline at the rest is greater than 95 beats per minutes (bpm).
Descrição

Resting heart rate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1821417
patient has contraindications for cardio-pulmonary exercise testing, including but not limited to, unstable angina, decompensated heart failure, active pericarditis or myocarditis and ecg st-segment shift > 2mm at the resting.
Descrição

Medical contraindication Cardiopulmonary Exercise Test | Angina, Unstable | Decompensated cardiac failure | Pericarditis | Myocarditis | ECG ST segment changes Resting

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2959886
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0581377
UMLS CUI [4]
C0031046
UMLS CUI [5]
C0027059
UMLS CUI [6,1]
C0232326
UMLS CUI [6,2]
C0035253
new york heart association class iv.
Descrição

New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275491
less than 45 days after myocardial infarction.
Descrição

Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
less than 3 months after acute heart failure.
Descrição

Acute heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0264714
patient has uncontrolled hypertension.
Descrição

Uncontrolled hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
patient is pregnant.
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
patient has a medical condition that would limit study participation.
Descrição

Medical condition Study Subject Participation Status Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
patient is enrolled in a concurrent study that may affect the outcome of this study.
Descrição

Study Subject Participation Status Affecting Research results

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
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Similar models

Eligibility Heart Failure NCT02358603

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is greater than 18 years of age and less than 70 years of old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patient is willing and able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Chronic heart failure Stable
Item
patient has been diagnosed with stable chronic hf according to european society of cardiology 2012 hf guidance.
boolean
C0264716 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
New York Heart Association Classification | Heart failure with preserved ejection fraction [HFpEF] | Heart failure with reduced ejection fraction
Item
new york heart association class i- iii, including with hf with preserved ejection fraction and hf with reduced ejection fraction patients.
boolean
C1275491 (UMLS CUI [1])
C4509226 (UMLS CUI [2])
C3839346 (UMLS CUI [3])
Ability Moderate Exercise
Item
patients can perform moderate exercise.
boolean
C0085732 (UMLS CUI [1,1])
C1513375 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction less than 55% but greater than 35%.
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
infoInformed Consent Unable | Informed Consent Unwilling
Item
patient is unable or unwilling to sign the patient informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Artificial cardiac pacemaker | ICD | CRT Device
Item
patient has implantable pacemaker, implantable cardiovert defibrillator (icd) or cardiac resynchronize therapy (crt) device.
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C2936377 (UMLS CUI [3])
Indication Quantity Artificial cardiac pacemaker | Indication Quantity ICD | Indication Quantity CRT Device
Item
patient has at least one pacemaker, icd or crt indications.
boolean
C3146298 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0030163 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0162589 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C2936377 (UMLS CUI [3,3])
Persistent atrial fibrillation
Item
patients has persistent atrial fibrillation (af).
boolean
C2585653 (UMLS CUI [1])
Resting heart rate
Item
patient whose hear rate baseline at the rest is greater than 95 beats per minutes (bpm).
boolean
C1821417 (UMLS CUI [1])
Medical contraindication Cardiopulmonary Exercise Test | Angina, Unstable | Decompensated cardiac failure | Pericarditis | Myocarditis | ECG ST segment changes Resting
Item
patient has contraindications for cardio-pulmonary exercise testing, including but not limited to, unstable angina, decompensated heart failure, active pericarditis or myocarditis and ecg st-segment shift > 2mm at the resting.
boolean
C1301624 (UMLS CUI [1,1])
C2959886 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0581377 (UMLS CUI [3])
C0031046 (UMLS CUI [4])
C0027059 (UMLS CUI [5])
C0232326 (UMLS CUI [6,1])
C0035253 (UMLS CUI [6,2])
New York Heart Association Classification
Item
new york heart association class iv.
boolean
C1275491 (UMLS CUI [1])
Myocardial Infarction
Item
less than 45 days after myocardial infarction.
boolean
C0027051 (UMLS CUI [1])
Acute heart failure
Item
less than 3 months after acute heart failure.
boolean
C0264714 (UMLS CUI [1])
Uncontrolled hypertension
Item
patient has uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
Pregnancy
Item
patient is pregnant.
boolean
C0032961 (UMLS CUI [1])
Medical condition Study Subject Participation Status Limited
Item
patient has a medical condition that would limit study participation.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Study Subject Participation Status Affecting Research results
Item
patient is enrolled in a concurrent study that may affect the outcome of this study.
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
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