ID

40488

Beschreibung

HeartTrends Heart Rate Variability (HRV) Algorithm for the Diagnosis of Myocardial Ischemia; ODM derived from: https://clinicaltrials.gov/show/NCT01657006

Link

https://clinicaltrials.gov/show/NCT01657006

Stichworte

Versionen (1)
  1. 25.04.20 25.04.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. April 2020

DOI

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Eligibility Ischemic Heart Disease NCT01657006

Englisch

Eligibility Ischemic Heart Disease NCT01657006

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 21
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
referral for exercise mpi by treating physicians
Beschreibung

Referral for Exercise Myocardial Perfusion Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C2350390
willing and able to provide written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
established ischemic heart disease
Beschreibung

Myocardial Ischemia Established

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0443211
atrial fibrillation or flutter
Beschreibung

Atrial Fibrillation | Atrial Flutter

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0004239
acute coronary syndrome
Beschreibung

Acute Coronary Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0948089
cardiac pacemaker
Beschreibung

Artificial cardiac pacemaker

Datentyp

boolean

Alias
UMLS CUI [1]
C0030163
clinical diagnosis of heart failure
Beschreibung

Heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
moderate or severe copd
Beschreibung

Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0730605
UMLS CUI [2]
C0730607
active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis
Beschreibung

Myocarditis | Pericarditis, Constrictive | Cardiomyopathy | Cardiac amyloidosis | Systemic amyloidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0027059
UMLS CUI [2]
C0031048
UMLS CUI [3]
C0878544
UMLS CUI [4]
C0268407
UMLS CUI [5]
C0268380
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;
Beschreibung

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

Datentyp

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
any illness that might reduce life expectancy to less than 1 year from screening
Beschreibung

Illness Reducing Life Expectancy

Datentyp

boolean

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

Left Bundle-Branch Block | Incomplete Bundle Branch Block | ST deviation Electrocardiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0023211
UMLS CUI [2]
C0259758
UMLS CUI [3,1]
C1116089
UMLS CUI [3,2]
C1623258
inability to perform an exercise stress test (i.e. orthopedical or neurological limitations)
Beschreibung

Exercise stress test Unable | Orthopedic problem | Neurologic Deficits

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015260
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C0029354
UMLS CUI [3]
C0521654
any significant established myocardial or valvular disease
Beschreibung

Cardiomyopathy Established | Valvular disease Established

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0878544
UMLS CUI [1,2]
C0443211
UMLS CUI [2,1]
C3258293
UMLS CUI [2,2]
C0443211
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Ähnliche Modelle

Eligibility Ischemic Heart Disease NCT01657006

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 21
boolean
C0001779 (UMLS CUI [1])
Referral for Exercise Myocardial Perfusion Imaging
Item
referral for exercise mpi by treating physicians
boolean
C2585524 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C2350390 (UMLS CUI [1,3])
Informed Consent
Item
willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Myocardial Ischemia Established
Item
established ischemic heart disease
boolean
C0151744 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
Atrial Fibrillation | Atrial Flutter
Item
atrial fibrillation or flutter
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
Acute Coronary Syndrome
Item
acute coronary syndrome
boolean
C0948089 (UMLS CUI [1])
Artificial cardiac pacemaker
Item
cardiac pacemaker
boolean
C0030163 (UMLS CUI [1])
Heart failure
Item
clinical diagnosis of heart failure
boolean
C0018801 (UMLS CUI [1])
Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease
Item
moderate or severe copd
boolean
C0730605 (UMLS CUI [1])
C0730607 (UMLS CUI [2])
Myocarditis | Pericarditis, Constrictive | Cardiomyopathy | Cardiac amyloidosis | Systemic amyloidosis
Item
active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis
boolean
C0027059 (UMLS CUI [1])
C0031048 (UMLS CUI [2])
C0878544 (UMLS CUI [3])
C0268407 (UMLS CUI [4])
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
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
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 | Incomplete Bundle Branch Block | ST deviation Electrocardiography
Item
left bundle branch block (lbbb), significant intra-ventricular conduction delay (ivcd) or significant (>1mm) st deviations on baseline ecg
boolean
C0023211 (UMLS CUI [1])
C0259758 (UMLS CUI [2])
C1116089 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
Exercise stress test Unable | Orthopedic problem | Neurologic Deficits
Item
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])
Cardiomyopathy Established | Valvular disease Established
Item
any significant established myocardial or valvular disease
boolean
C0878544 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C3258293 (UMLS CUI [2,1])
C0443211 (UMLS CUI [2,2])
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