ID

39614

Descripción

Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support; ODM derived from: https://clinicaltrials.gov/show/NCT01932294

Link

https://clinicaltrials.gov/show/NCT01932294

Palabras clave

Versiones (1)
  1. 4/2/20 4/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01932294

Inglés

Eligibility Heart Failure NCT01932294

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with advanced heart failure
Descripción

Heart failure Advanced

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205179
1. age 18-80 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. new york heart association class iii-iv heart failure for 45 of the last 60 days
Descripción

Heart failure New York Heart Association Classification Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [1,3]
C0449238
3. left ventricular ejection fraction ≤ 35%
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
4. heart failure diagnosis or typical symptoms for 12 months
Descripción

Heart failure | Symptoms Typical Duration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C3538928
UMLS CUI [2,3]
C0449238
5. use of evidence based oral medications (beta-blockers, ace-inhibitors/arbs, aldosterone antagonist) for at least 3 months prior to enrollment or documented medication contraindication or intolerance.
Descripción

Adrenergic beta-1 Receptor Antagonists Oral | Angiotensin-Converting Enzyme Inhibitors Oral | Angiotensin II receptor antagonist Oral | Aldosterone Antagonists Oral | Medical contraindication Pharmaceutical Preparations | Intolerance to Pharmaceutical Preparations

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304516
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0003015
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0521942
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0002007
UMLS CUI [4,2]
C1527415
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0013227
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0013227
6. hospitalization for heart failure within the previous 12 months (other than for elective procedure)
Descripción

Hospitalization Due to Heart Failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3898876
7. informed consent given
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
in addition, they must have at least one of the following:
Descripción

Criteria Additional Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C1265611
an additional unplanned hospitalization during the previous 12 months for a total of at least 2 inpatient hospitalizations lasting >24 hours with heart failure as the primary or secondary diagnosis within the previous 12 months
Descripción

Hospitalization Due to Heart Failure Additional | Hospitalization Quantity Inpatient stay | Heart failure Principal diagnosis | Heart failure Secondary diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0420512
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0332137
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C0332138
1. peak oxygen uptake (vo2) <55% of age- and sex-predicted (using wasserman equation) or a peak vo2 ≤16 ml/kg/min for men and ≤14 ml/kg/min for women in a test with an rer >1.08 on cardiopulmonary exercise testing.
Descripción

Oxygen uptake Peak level | Age | Gender | Other Coding | Respiratory Exchange Ratio Cardiopulmonary Exercise Test

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0429627
UMLS CUI [1,2]
C0444505
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0079399
UMLS CUI [4]
C3846158
UMLS CUI [5,1]
C4049826
UMLS CUI [5,2]
C2959886
2. 6-minute walk distance <300 meters without non-cardiac limitation.
Descripción

6-Minute Walk Test Distance | Limitation Absent | Exception Limitation cardiac

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0012751
UMLS CUI [2,1]
C0449295
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0449295
UMLS CUI [3,3]
C0018787
3. serum bnp > 1000 (nt-probnp > 4000 pg/ml) as outpatient or at hospital discharge.
Descripción

Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement | Outpatient | Discharge from hospital

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
UMLS CUI [3]
C0029921
UMLS CUI [4]
C0586003
seattle heart failure model score > 1.5.
Descripción

Heart failure Score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0449820
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age >80 years or <18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. non-cardiac diagnosis anticipated to limit 2-year survival (≥30-50% mortality within 2 years from non-cardiac diagnosis)
Descripción

Diagnosis Survival Limited | Exception Heart Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0038952
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
3. primary functional limitation from non-cardiac diagnosis even if not likely to limit survival
Descripción

Primary functional limitation | Diagnosis Except Heart Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4018823
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0018799
4. qrs > 120msec and planned biventricular pacemaker implant or biventricular pacemaker implantation within past 90 days
Descripción

QRS duration | Biventricular pacemaker insertion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0429025
UMLS CUI [2]
C3805138
5. current home intravenous inotrope therapy
Descripción

Inotropic agent Intravenous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C1522726
6. chronic hemodialysis or peritoneal dialysis
Descripción

Chronic haemodialysis | Chronic peritoneal dialysis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1740835
UMLS CUI [2]
C0455150
7. scheduled for non-ventricular assist device cardiac surgery on current hospital admission
Descripción

Heart-Assist Device Surgery Scheduled | Involvement with Ventricle Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018831
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0018827
UMLS CUI [2,3]
C0332197
8. obvious anatomical or other major contra-indication to any cardiac surgery in the future (e.g. previous pneumonectomy, advanced connective tissue disease)
Descripción

Medical contraindication anatomical Cardiac Surgery | Medical contraindication Major Cardiac Surgery | Pneumonectomy | Connective Tissue Disease Advanced

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0220784
UMLS CUI [1,3]
C0018821
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0018821
UMLS CUI [3]
C0032284
UMLS CUI [4,1]
C0009782
UMLS CUI [4,2]
C0205179
9. actively listed for heart transplant as unos status 1 or 2
Descripción

Patient on waiting list Heart Transplantation | UNOS Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0422768
UMLS CUI [1,2]
C0018823
UMLS CUI [2,1]
C3826868
UMLS CUI [2,2]
C0449438
10. history of cardiac amyloidosis
Descripción

Amyloidosis Cardiac

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002726
UMLS CUI [1,2]
C1522601
11. dominant lesion of at least moderate aortic or mitral stenosis or congenital structural heart defect.
Descripción

Aortic Valve Stenosis Moderate | Aortic stenosis severe | MITRAL STENOSIS MODERATE | Mitral Valve Stenosis Severe | Congenital Heart Defect structural

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003507
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C3806272
UMLS CUI [3]
C0746601
UMLS CUI [4,1]
C0026269
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0018798
UMLS CUI [5,2]
C0678594
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Similar models

Eligibility Heart Failure NCT01932294

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Advanced
Item
patients with advanced heart failure
boolean
C0018801 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Age
Item
1. age 18-80 years
boolean
C0001779 (UMLS CUI [1])
Heart failure New York Heart Association Classification Duration
Item
2. new york heart association class iii-iv heart failure for 45 of the last 60 days
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
3. left ventricular ejection fraction ≤ 35%
boolean
C0428772 (UMLS CUI [1])
Heart failure | Symptoms Typical Duration
Item
4. heart failure diagnosis or typical symptoms for 12 months
boolean
C0018801 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C3538928 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Adrenergic beta-1 Receptor Antagonists Oral | Angiotensin-Converting Enzyme Inhibitors Oral | Angiotensin II receptor antagonist Oral | Aldosterone Antagonists Oral | Medical contraindication Pharmaceutical Preparations | Intolerance to Pharmaceutical Preparations
Item
5. use of evidence based oral medications (beta-blockers, ace-inhibitors/arbs, aldosterone antagonist) for at least 3 months prior to enrollment or documented medication contraindication or intolerance.
boolean
C0304516 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0521942 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0002007 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
Hospitalization Due to Heart Failure
Item
6. hospitalization for heart failure within the previous 12 months (other than for elective procedure)
boolean
C3898876 (UMLS CUI [1])
Informed Consent
Item
7. informed consent given
boolean
C0021430 (UMLS CUI [1])
Criteria Additional Quantity
Item
in addition, they must have at least one of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Hospitalization Due to Heart Failure Additional | Hospitalization Quantity Inpatient stay | Heart failure Principal diagnosis | Heart failure Secondary diagnosis
Item
an additional unplanned hospitalization during the previous 12 months for a total of at least 2 inpatient hospitalizations lasting >24 hours with heart failure as the primary or secondary diagnosis within the previous 12 months
boolean
C3898876 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0420512 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3,1])
C0332137 (UMLS CUI [3,2])
C0018801 (UMLS CUI [4,1])
C0332138 (UMLS CUI [4,2])
Oxygen uptake Peak level | Age | Gender | Other Coding | Respiratory Exchange Ratio Cardiopulmonary Exercise Test
Item
1. peak oxygen uptake (vo2) <55% of age- and sex-predicted (using wasserman equation) or a peak vo2 ≤16 ml/kg/min for men and ≤14 ml/kg/min for women in a test with an rer >1.08 on cardiopulmonary exercise testing.
boolean
C0429627 (UMLS CUI [1,1])
C0444505 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
C4049826 (UMLS CUI [5,1])
C2959886 (UMLS CUI [5,2])
6-Minute Walk Test Distance | Limitation Absent | Exception Limitation cardiac
Item
2. 6-minute walk distance <300 meters without non-cardiac limitation.
boolean
C0430515 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
C0449295 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0449295 (UMLS CUI [3,2])
C0018787 (UMLS CUI [3,3])
Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement | Outpatient | Discharge from hospital
Item
3. serum bnp > 1000 (nt-probnp > 4000 pg/ml) as outpatient or at hospital discharge.
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
C0029921 (UMLS CUI [3])
C0586003 (UMLS CUI [4])
Heart failure Score
Item
seattle heart failure model score > 1.5.
boolean
C0018801 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age >80 years or <18 years
boolean
C0001779 (UMLS CUI [1])
Diagnosis Survival Limited | Exception Heart Diseases
Item
2. non-cardiac diagnosis anticipated to limit 2-year survival (≥30-50% mortality within 2 years from non-cardiac diagnosis)
boolean
C0011900 (UMLS CUI [1,1])
C0038952 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
Primary functional limitation | Diagnosis Except Heart Disease
Item
3. primary functional limitation from non-cardiac diagnosis even if not likely to limit survival
boolean
C4018823 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0018799 (UMLS CUI [2,3])
QRS duration | Biventricular pacemaker insertion
Item
4. qrs > 120msec and planned biventricular pacemaker implant or biventricular pacemaker implantation within past 90 days
boolean
C0429025 (UMLS CUI [1])
C3805138 (UMLS CUI [2])
Inotropic agent Intravenous
Item
5. current home intravenous inotrope therapy
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Chronic haemodialysis | Chronic peritoneal dialysis
Item
6. chronic hemodialysis or peritoneal dialysis
boolean
C1740835 (UMLS CUI [1])
C0455150 (UMLS CUI [2])
Heart-Assist Device Surgery Scheduled | Involvement with Ventricle Absent
Item
7. scheduled for non-ventricular assist device cardiac surgery on current hospital admission
boolean
C0018831 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C0018827 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Medical contraindication anatomical Cardiac Surgery | Medical contraindication Major Cardiac Surgery | Pneumonectomy | Connective Tissue Disease Advanced
Item
8. obvious anatomical or other major contra-indication to any cardiac surgery in the future (e.g. previous pneumonectomy, advanced connective tissue disease)
boolean
C1301624 (UMLS CUI [1,1])
C0220784 (UMLS CUI [1,2])
C0018821 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0018821 (UMLS CUI [2,3])
C0032284 (UMLS CUI [3])
C0009782 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
Patient on waiting list Heart Transplantation | UNOS Status
Item
9. actively listed for heart transplant as unos status 1 or 2
boolean
C0422768 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C3826868 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
Amyloidosis Cardiac
Item
10. history of cardiac amyloidosis
boolean
C0002726 (UMLS CUI [1,1])
C1522601 (UMLS CUI [1,2])
Aortic Valve Stenosis Moderate | Aortic stenosis severe | MITRAL STENOSIS MODERATE | Mitral Valve Stenosis Severe | Congenital Heart Defect structural
Item
11. dominant lesion of at least moderate aortic or mitral stenosis or congenital structural heart defect.
boolean
C0003507 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3806272 (UMLS CUI [2])
C0746601 (UMLS CUI [3])
C0026269 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0018798 (UMLS CUI [5,1])
C0678594 (UMLS CUI [5,2])
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