ID

39614

Description

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

Keywords

  1. 2/4/20 2/4/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 4, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Heart Failure NCT01932294

Eligibility Heart Failure NCT01932294

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with advanced heart failure
Description

Heart failure Advanced

Data type

boolean

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

Age

Data type

boolean

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

Heart failure New York Heart Association Classification Duration

Data type

boolean

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

Left ventricular ejection fraction

Data type

boolean

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

Heart failure | Symptoms Typical Duration

Data type

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.
Description

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

Data type

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)
Description

Hospitalization Due to Heart Failure

Data type

boolean

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

Informed Consent

Data type

boolean

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

Criteria Additional Quantity

Data type

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
Description

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

Heart failure Score

Data type

boolean

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

Exclusion Criteria

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

Age

Data type

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)
Description

Diagnosis Survival Limited | Exception Heart Diseases

Data type

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
Description

Primary functional limitation | Diagnosis Except Heart Disease

Data type

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
Description

QRS duration | Biventricular pacemaker insertion

Data type

boolean

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

Inotropic agent Intravenous

Data type

boolean

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

Chronic haemodialysis | Chronic peritoneal dialysis

Data type

boolean

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

Heart-Assist Device Surgery Scheduled | Involvement with Ventricle Absent

Data type

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)
Description

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

Data type

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
Description

Patient on waiting list Heart Transplantation | UNOS Status

Data type

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
Description

Amyloidosis Cardiac

Data type

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.
Description

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

Data type

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

Similar models

Eligibility Heart Failure NCT01932294

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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