ID

35965

Beskrivning

HeartTrends HRV Algorithm for the Detection of Myocardial Ischemia; ODM derived from: https://clinicaltrials.gov/show/NCT02201017

Länk

https://clinicaltrials.gov/show/NCT02201017

Nyckelord

Versioner (1)
  1. 07/04/2019 07/04/2019 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 de abril de 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Rate Variability Ischemia Detection NCT02201017

Engelsk

Eligibility Heart Rate Variability Ischemia Detection NCT02201017

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 21
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
no known cad
Beskrivning

Coronary Artery Disease Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0332197
referral for est due to either one of the following two indications:
Beskrivning

Referral for Exercise stress test | Indication Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C0015260
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1265611
1. chest pain syndrome or equivocal angina in subjects with intermediate pretest probability of cad according to the 2002 updated guidelines for exercise stress examination.1 (see definition of intermediate pretest probability of cad in supplementary appendix table at the end of this document); or
Beskrivning

Chest pain syndrome | Angina Pectoris Equivocal | Pretest Probability Coronary Artery Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0694545
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0332241
UMLS CUI [3,1]
C0033101
UMLS CUI [3,2]
C0033204
UMLS CUI [3,3]
C1956346
2. asymptomatic subjects with diabetes mellitus referred to est for risk assessment prior to initiation of an exercise program.
Beskrivning

Study Subject Asymptomatic | Diabetes Mellitus | Referral to Exercise stress test | Risk Assessment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0231221
UMLS CUI [2]
C0011849
UMLS CUI [3,1]
C2585021
UMLS CUI [3,2]
C0015260
UMLS CUI [4]
C0086930
willing and able to provide written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. acute coronary syndrome
Beskrivning

Acute Coronary Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
2. established cad
Beskrivning

Coronary Artery Disease Established

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0443211
3. atrial fibrillation or flutter
Beskrivning

Atrial Fibrillation | Atrial Flutter

Datatyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0004239
4. cardiac pacemaker
Beskrivning

Artificial cardiac pacemaker

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
5. clinical diagnosis of heart failure
Beskrivning

Heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
6. severe copd (fev1< 50% predicted value)
Beskrivning

Severe chronic obstructive pulmonary disease | Percent predicted FEV1

Datatyp

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C0730561
7. active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis
Beskrivning

Myocarditis | Pericarditis, Constrictive | Cardiomyopathy | Amyloidosis cardiac | Systemic amyloidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027059
UMLS CUI [2]
C0031048
UMLS CUI [3]
C0878544
UMLS CUI [4,1]
C0002726
UMLS CUI [4,2]
C0018787
UMLS CUI [5]
C0268380
8. known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
Beskrivning

Substance Dependence | Factor Interferes with Completion of clinical trial | Factor Interferes with Interpretation Research results | Factor Study Subject Participation Status Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C1521761
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1548788
9. any illness that might reduce life expectancy to less than 1 year from screening
Beskrivning

Illness Reducing Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0023671
10. left bundle branch block (lbbb), significant intra-ventricular conduction delay (ivcd) or significant (>1mm) st deviations on baseline ecg
Beskrivning

Left Bundle-Branch Block | Intraventricular conduction defect | ST deviation Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0023211
UMLS CUI [2]
C0264909
UMLS CUI [3,1]
C1116089
UMLS CUI [3,2]
C1623258
11. inability to perform an exercise stress test (i.e. orthopedical or neurological limitations)
Beskrivning

Exercise stress test Unable | Orthopedic problem | Neurologic Deficits

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015260
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C0029354
UMLS CUI [3]
C0521654
12. any significant valvular disease defined as:
Beskrivning

Valvular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C3258293
established valvular regurgitation or stenosis abnormality above moderate severity 13. bmi >35 kg/m2 14. recent (< 6 months) history of pulmonary embolism
Beskrivning

Valvular regurgitation Established | Stenosis Severe | Body mass index | Pulmonary Embolism

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042300
UMLS CUI [1,2]
C0443211
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C1305855
UMLS CUI [4]
C0034065
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Similar models

Eligibility Heart Rate Variability Ischemia Detection NCT02201017

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 21
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease Absent
Item
no known cad
boolean
C1956346 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Referral for Exercise stress test | Indication Quantity
Item
referral for est due to either one of the following two indications:
boolean
C2585524 (UMLS CUI [1,1])
C0015260 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Chest pain syndrome | Angina Pectoris Equivocal | Pretest Probability Coronary Artery Disease
Item
1. chest pain syndrome or equivocal angina in subjects with intermediate pretest probability of cad according to the 2002 updated guidelines for exercise stress examination.1 (see definition of intermediate pretest probability of cad in supplementary appendix table at the end of this document); or
boolean
C0694545 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0332241 (UMLS CUI [2,2])
C0033101 (UMLS CUI [3,1])
C0033204 (UMLS CUI [3,2])
C1956346 (UMLS CUI [3,3])
Study Subject Asymptomatic | Diabetes Mellitus | Referral to Exercise stress test | Risk Assessment
Item
2. asymptomatic subjects with diabetes mellitus referred to est for risk assessment prior to initiation of an exercise program.
boolean
C0681850 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C2585021 (UMLS CUI [3,1])
C0015260 (UMLS CUI [3,2])
C0086930 (UMLS CUI [4])
Informed Consent
Item
willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Coronary Syndrome
Item
1. acute coronary syndrome
boolean
C0948089 (UMLS CUI [1])
Coronary Artery Disease Established
Item
2. established cad
boolean
C1956346 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
Atrial Fibrillation | Atrial Flutter
Item
3. atrial fibrillation or flutter
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
Artificial cardiac pacemaker
Item
4. cardiac pacemaker
boolean
C0030163 (UMLS CUI [1])
Heart failure
Item
5. clinical diagnosis of heart failure
boolean
C0018801 (UMLS CUI [1])
Severe chronic obstructive pulmonary disease | Percent predicted FEV1
Item
6. severe copd (fev1< 50% predicted value)
boolean
C0730607 (UMLS CUI [1])
C0730561 (UMLS CUI [2])
Myocarditis | Pericarditis, Constrictive | Cardiomyopathy | Amyloidosis cardiac | Systemic amyloidosis
Item
7. active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis
boolean
C0027059 (UMLS CUI [1])
C0031048 (UMLS CUI [2])
C0878544 (UMLS CUI [3])
C0002726 (UMLS CUI [4,1])
C0018787 (UMLS CUI [4,2])
C0268380 (UMLS CUI [5])
Substance Dependence | Factor Interferes with Completion of clinical trial | Factor Interferes with Interpretation Research results | Factor Study Subject Participation Status Inappropriate
Item
8. known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
boolean
C0038580 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C1521761 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
Illness Reducing Life Expectancy
Item
9. any illness that might reduce life expectancy to less than 1 year from screening
boolean
C0221423 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Left Bundle-Branch Block | Intraventricular conduction defect | ST deviation Electrocardiography
Item
10. left bundle branch block (lbbb), significant intra-ventricular conduction delay (ivcd) or significant (>1mm) st deviations on baseline ecg
boolean
C0023211 (UMLS CUI [1])
C0264909 (UMLS CUI [2])
C1116089 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
Exercise stress test Unable | Orthopedic problem | Neurologic Deficits
Item
11. inability to perform an exercise stress test (i.e. orthopedical or neurological limitations)
boolean
C0015260 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0029354 (UMLS CUI [2])
C0521654 (UMLS CUI [3])
Valvular disease
Item
12. any significant valvular disease defined as:
boolean
C3258293 (UMLS CUI [1])
Valvular regurgitation Established | Stenosis Severe | Body mass index | Pulmonary Embolism
Item
established valvular regurgitation or stenosis abnormality above moderate severity 13. bmi >35 kg/m2 14. recent (< 6 months) history of pulmonary embolism
boolean
C0042300 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C1261287 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1305855 (UMLS CUI [3])
C0034065 (UMLS CUI [4])
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