ID

39415

Beschrijving

One-year Outcomes of Electromechanical Activation Time (EMAT)-Guided vs. Symptom-guided Heart Failure Therapy in Acute Heart Failure Syndrome (AHFS) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01298232

Link

https://clinicaltrials.gov/show/NCT01298232

Trefwoorden

Versies (1)
  1. 09-01-20 09-01-20 -
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See clinicaltrials.gov

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9 januari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01298232

Engels

Eligibility Heart Failure NCT01298232

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients who are hospitalized due to ahfs and have a plasma nt-probnp ≥ 1600 pg/ml at admission.
Beschrijving

Hospitalization Due to Acute heart failure | N-Terminal ProB-type Natriuretic Peptide Measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0264714
UMLS CUI [2]
C3272900
2. patients give written consents to participate in the study.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with an implanted pacemaker.
Beschrijving

Pacemaker implant

Datatype

boolean

Alias
UMLS CUI [1]
C0848753
2. patients with chronic kidney disease, stage 5 and warranted dialysis.
Beschrijving

Chronic Kidney Disease Stage | Dialysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
UMLS CUI [2]
C0011946
3. patients with hypertrophic obstructive cardiomyopathy.
Beschrijving

Hypertrophic Cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0007194
4. patients with cardiac temponade or constrictive pericarditis.
Beschrijving

Cardiac Tamponade | Pericarditis, Constrictive

Datatype

boolean

Alias
UMLS CUI [1]
C0007177
UMLS CUI [2]
C0031048
5. acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (pci) or carotid angioplasty, within the past 1 months prior to index hospitalization.
Beschrijving

Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiac Surgery procedure | Carotid surgery | Vascular Surgical Procedures Major | Percutaneous Coronary Intervention | Carotid angioplasty

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0018821
UMLS CUI [5]
C0741984
UMLS CUI [6,1]
C0042381
UMLS CUI [6,2]
C0205164
UMLS CUI [7]
C1532338
UMLS CUI [8]
C3203476
6. coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after discharge at index hospitalization.
Beschrijving

Coronary Artery Disease | Carotid Artery Disease | Requirement Operative Surgical Procedure | Requirement Percutaneous Coronary Intervention

Datatype

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0007273
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0543467
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C1532338
7. patients with left ventricular assistance device (lvad device).
Beschrijving

Left ventricular assist device

Datatype

boolean

Alias
UMLS CUI [1]
C0181598
8. documented ventricular arrhythmia with syncope episodes within past 3 months, prior to index hospitalization that is untreated.
Beschrijving

Ventricular arrhythmia Untreated | Ventricular arrhythmia with Syncope

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0085612
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0039070
9. symptomatic bradycardia or second or third degree heart block without a pacemaker.
Beschrijving

BRADYCARDIA SYMPTOMATIC | Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0741627
UMLS CUI [2]
C0264906
UMLS CUI [3]
C0151517
UMLS CUI [4,1]
C0030163
UMLS CUI [4,2]
C0332197
10. implantation of a crt (cardiac resynchronization therapy) device within the prior 1 month before index hospitalization or intent to implant a crt device.
Beschrijving

Implantation of CRT-D | Implantation of CRT-D intended

Datatype

boolean

Alias
UMLS CUI [1]
C1135480
UMLS CUI [2,1]
C1135480
UMLS CUI [2,2]
C1283828
11. presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation.
Beschrijving

Disease of mitral valve | Aortic valve disorder | Exception Mitral Valve Insufficiency Secondary to Left ventricular dilatation

Datatype

boolean

Alias
UMLS CUI [1]
C0026265
UMLS CUI [2]
C1260873
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0026266
UMLS CUI [3,3]
C0175668
UMLS CUI [3,4]
C0344911
12. presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis.
Beschrijving

Obstructive lesion Outflow tract of left ventricle | Aortic Valve Stenosis | Subaortic stenosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C3872566
UMLS CUI [1,2]
C0225912
UMLS CUI [2]
C0003507
UMLS CUI [3]
C0340375
13. severe primary pulmonary, renal or hepatic disease.
Beschrijving

Lung disease Severe | Kidney Disease Severe | Liver disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
14. presence of any other disease with a life expectancy of < 1 year.
Beschrijving

Disease | Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0023671
15. subjects get pregnant or will be pregnant within 1 month.
Beschrijving

Pregnancy | Pregnancy Impending

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332190
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Similar models

Eligibility Heart Failure NCT01298232

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hospitalization Due to Acute heart failure | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
1. patients who are hospitalized due to ahfs and have a plasma nt-probnp ≥ 1600 pg/ml at admission.
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0264714 (UMLS CUI [1,3])
C3272900 (UMLS CUI [2])
Informed Consent
Item
2. patients give written consents to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pacemaker implant
Item
1. patients with an implanted pacemaker.
boolean
C0848753 (UMLS CUI [1])
Chronic Kidney Disease Stage | Dialysis
Item
2. patients with chronic kidney disease, stage 5 and warranted dialysis.
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
C0011946 (UMLS CUI [2])
Hypertrophic Cardiomyopathy
Item
3. patients with hypertrophic obstructive cardiomyopathy.
boolean
C0007194 (UMLS CUI [1])
Cardiac Tamponade | Pericarditis, Constrictive
Item
4. patients with cardiac temponade or constrictive pericarditis.
boolean
C0007177 (UMLS CUI [1])
C0031048 (UMLS CUI [2])
Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack | Cardiac Surgery procedure | Carotid surgery | Vascular Surgical Procedures Major | Percutaneous Coronary Intervention | Carotid angioplasty
Item
5. acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (pci) or carotid angioplasty, within the past 1 months prior to index hospitalization.
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0018821 (UMLS CUI [4])
C0741984 (UMLS CUI [5])
C0042381 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C1532338 (UMLS CUI [7])
C3203476 (UMLS CUI [8])
Coronary Artery Disease | Carotid Artery Disease | Requirement Operative Surgical Procedure | Requirement Percutaneous Coronary Intervention
Item
6. coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after discharge at index hospitalization.
boolean
C1956346 (UMLS CUI [1])
C0007273 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C1532338 (UMLS CUI [4,2])
Left ventricular assist device
Item
7. patients with left ventricular assistance device (lvad device).
boolean
C0181598 (UMLS CUI [1])
Ventricular arrhythmia Untreated | Ventricular arrhythmia with Syncope
Item
8. documented ventricular arrhythmia with syncope episodes within past 3 months, prior to index hospitalization that is untreated.
boolean
C0085612 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0085612 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0039070 (UMLS CUI [2,3])
BRADYCARDIA SYMPTOMATIC | Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent
Item
9. symptomatic bradycardia or second or third degree heart block without a pacemaker.
boolean
C0741627 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0030163 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Implantation of CRT-D | Implantation of CRT-D intended
Item
10. implantation of a crt (cardiac resynchronization therapy) device within the prior 1 month before index hospitalization or intent to implant a crt device.
boolean
C1135480 (UMLS CUI [1])
C1135480 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
Disease of mitral valve | Aortic valve disorder | Exception Mitral Valve Insufficiency Secondary to Left ventricular dilatation
Item
11. presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation.
boolean
C0026265 (UMLS CUI [1])
C1260873 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0026266 (UMLS CUI [3,2])
C0175668 (UMLS CUI [3,3])
C0344911 (UMLS CUI [3,4])
Obstructive lesion Outflow tract of left ventricle | Aortic Valve Stenosis | Subaortic stenosis
Item
12. presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis.
boolean
C3872566 (UMLS CUI [1,1])
C0225912 (UMLS CUI [1,2])
C0003507 (UMLS CUI [2])
C0340375 (UMLS CUI [3])
Lung disease Severe | Kidney Disease Severe | Liver disease Severe
Item
13. severe primary pulmonary, renal or hepatic disease.
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Disease | Life Expectancy
Item
14. presence of any other disease with a life expectancy of < 1 year.
boolean
C0012634 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Pregnancy | Pregnancy Impending
Item
15. subjects get pregnant or will be pregnant within 1 month.
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
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