ID

4942

Description

ODM derived from http://clinicaltrials.gov/show/NCT00628745

Link

http://clinicaltrials.gov/show/NCT00628745

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
Uploaded on

April 15, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00628745 Transthyretin Mutations

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Written informed consent.
Description

Written informed consent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
Patient has confirmed: genotyped TTR mutation with or without a diagnosis of TTR-associated amyloidosis (e.g., ATTR-PN, ATTR-CM), or Wild-type TTR-associated amyloidosis with cardiomyopathy (wild-type ATTR-CM).
Description

Patient has confirmed: genotyped TTR mutation with or without a diagnosis of TTR-associated amyloidosis (e.g., ATTR-PN, ATTR-CM), or Wild-type TTR-associated amyloidosis with cardiomyopathy (wild-type ATTR-CM).

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0017431
UMLS CUI 2011AA
C0032923
SNOMED CT 2011_0131
37959007
LOINC Version 232
MTHU004200
UMLS CUI 2011AA
C0026882
SNOMED CT 2011_0131
55446002
UMLS CUI 2011AA
C0032923
SNOMED CT 2011_0131
37959007
LOINC Version 232
MTHU004200
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0002726
SNOMED CT 2011_0131
17602002
MedDRA 14.1
10002022
LOINC Version 232
E85
ICD-10-CM Version 2010
277.3
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0032923
SNOMED CT 2011_0131
37959007
LOINC Version 232
MTHU004200
UMLS CUI 2011AA
C0206247
SNOMED CT 2011_0131
193187004
UMLS CUI 2011AA
C0268407
SNOMED CT 2011_0131
16573007
MedDRA 14.1
10007509
UMLS CUI 2011AA
C0678926
UMLS CUI 2011AA
CL411823
SNOMED CT 2011_0131
85898001
MedDRA 14.1
10007636
ICD-10-CM Version 2010
I42.9
ICD-9-CM Version 2011
425
Description

Confirmation of wild-type ATTR-CM will be determined by one of the following set of criteria (A or B):

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0678926
UMLS CUI 2011AA
C0032923
SNOMED CT 2011_0131
37959007
LOINC Version 232
MTHU004200
UMLS CUI 2011AA
C0268407
SNOMED CT 2011_0131
16573007
MedDRA 14.1
10007509
UMLS CUI 2011AA
C0521095
SNOMED CT 2011_0131
436000
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C1705195
UMLS CUI 2011AA
CL414621
A. Presence of amyloid in cardiac biopsy tissue confirmed as TTR amyloid by immunohistochemistry and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing
Description

A. Presence of amyloid in cardiac biopsy tissue confirmed as TTR amyloid by immunohistochemistry and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0002716
UMLS CUI 2011AA
C1272575
SNOMED CT 2011_0131
386108004
UMLS CUI 2011AA
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0032923
SNOMED CT 2011_0131
37959007
LOINC Version 232
MTHU004200
UMLS CUI 2011AA
C0002716
UMLS CUI 2011AA
C0020986
UMLS CUI 2011AA
C0017431
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0026882
SNOMED CT 2011_0131
55446002
UMLS CUI 2011AA
C1421224
UMLS CUI 2011AA
C0678926
UMLS CUI 2011AA
C0002085
SNOMED CT 2011_0131
9109004
UMLS CUI 2011AA
C0679560
SNOMED CT 2011_0131
405824009
B. Evidence of cardiac involvement by echocardiogram as defined by mean left ventricle wall thickness of > 12 mm, and presence of amyloid in non-cardiac tissue confirmed as TTR amyloid by immunohistochemistry, and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing.
Description

B. Evidence of cardiac involvement by echocardiogram as defined by mean left ventricle wall thickness of > 12 mm, and presence of amyloid in non-cardiac tissue confirmed as TTR amyloid by immunohistochemistry, and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C1522601
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C2243117
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0444504
SNOMED CT 2011_0131
255586005
UMLS CUI 2011AA
C0504053
UMLS CUI 2011AA
C1280412
SNOMED CT 2011_0131
246703001
LOINC Version 232
MTHU002984
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0002716
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1522601
UMLS CUI 2011AA
C0040300
SNOMED CT 2011_0131
85756007
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0032923
SNOMED CT 2011_0131
37959007
LOINC Version 232
MTHU004200
UMLS CUI 2011AA
C0002716
UMLS CUI 2011AA
C0021044
SNOMED CT 2011_0131
117617002
MedDRA 14.1
10059656
UMLS CUI 2011AA
C0017431
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0026882
SNOMED CT 2011_0131
55446002
UMLS CUI 2011AA
C1421224
UMLS CUI 2011AA
C0678926
UMLS CUI 2011AA
C0002085
SNOMED CT 2011_0131
9109004
UMLS CUI 2011AA
C0679560
SNOMED CT 2011_0131
405824009
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patient has primary or secondary amyloidosis.
Description

Patient has primary or secondary amyloidosis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0268381
SNOMED CT 2011_0131
23132008
MedDRA 14.1
10036673
UMLS CUI 2011AA
C0221014
SNOMED CT 2011_0131
281034005
MedDRA 14.1
10039811
ICD-10-CM Version 2010
E85.3
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Written informed consent.
Item
Written informed consent.
boolean
C0021430 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
Patient has confirmed: genotyped TTR mutation with or without a diagnosis of TTR-associated amyloidosis (e.g., ATTR-PN, ATTR-CM), or Wild-type TTR-associated amyloidosis with cardiomyopathy (wild-type ATTR-CM).
Item
Patient has confirmed: genotyped TTR mutation with or without a diagnosis of TTR-associated amyloidosis (e.g., ATTR-PN, ATTR-CM), or Wild-type TTR-associated amyloidosis with cardiomyopathy (wild-type ATTR-CM).
boolean
C0750484 (UMLS CUI 2011AA)
C0017431 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0002726 (UMLS CUI 2011AA)
17602002 (SNOMED CT 2011_0131)
10002022 (MedDRA 14.1)
E85 (LOINC Version 232)
277.3 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0206247 (UMLS CUI 2011AA)
193187004 (SNOMED CT 2011_0131)
C0268407 (UMLS CUI 2011AA)
16573007 (SNOMED CT 2011_0131)
10007509 (MedDRA 14.1)
C0678926 (UMLS CUI 2011AA)
CL411823 (UMLS CUI 2011AA)
85898001 (SNOMED CT 2011_0131)
10007636 (MedDRA 14.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
Confirmation of wild-type ATTR-CM will be determined by one of the following set of criteria (A or B):
Item
boolean
C0750484 (UMLS CUI 2011AA)
C0678926 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0268407 (UMLS CUI 2011AA)
16573007 (SNOMED CT 2011_0131)
10007509 (MedDRA 14.1)
C0521095 (UMLS CUI 2011AA)
436000 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1705195 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
A. Presence of amyloid in cardiac biopsy tissue confirmed as TTR amyloid by immunohistochemistry and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing
Item
A. Presence of amyloid in cardiac biopsy tissue confirmed as TTR amyloid by immunohistochemistry and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0002716 (UMLS CUI 2011AA)
C1272575 (UMLS CUI 2011AA)
386108004 (SNOMED CT 2011_0131)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0750484 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0002716 (UMLS CUI 2011AA)
C0020986 (UMLS CUI 2011AA)
C0017431 (UMLS CUI 2011AA)
C0750484 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C1421224 (UMLS CUI 2011AA)
C0678926 (UMLS CUI 2011AA)
C0002085 (UMLS CUI 2011AA)
9109004 (SNOMED CT 2011_0131)
C0679560 (UMLS CUI 2011AA)
405824009 (SNOMED CT 2011_0131)
B. Evidence of cardiac involvement by echocardiogram as defined by mean left ventricle wall thickness of > 12 mm, and presence of amyloid in non-cardiac tissue confirmed as TTR amyloid by immunohistochemistry, and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing.
Item
B. Evidence of cardiac involvement by echocardiogram as defined by mean left ventricle wall thickness of > 12 mm, and presence of amyloid in non-cardiac tissue confirmed as TTR amyloid by immunohistochemistry, and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing.
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1522601 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C2243117 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0444504 (UMLS CUI 2011AA)
255586005 (SNOMED CT 2011_0131)
C0504053 (UMLS CUI 2011AA)
C1280412 (UMLS CUI 2011AA)
246703001 (SNOMED CT 2011_0131)
MTHU002984 (LOINC Version 232)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0002716 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1522601 (UMLS CUI 2011AA)
C0040300 (UMLS CUI 2011AA)
85756007 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0032923 (UMLS CUI 2011AA)
37959007 (SNOMED CT 2011_0131)
MTHU004200 (LOINC Version 232)
C0002716 (UMLS CUI 2011AA)
C0021044 (UMLS CUI 2011AA)
117617002 (SNOMED CT 2011_0131)
10059656 (MedDRA 14.1)
C0017431 (UMLS CUI 2011AA)
C0750484 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C1421224 (UMLS CUI 2011AA)
C0678926 (UMLS CUI 2011AA)
C0002085 (UMLS CUI 2011AA)
9109004 (SNOMED CT 2011_0131)
C0679560 (UMLS CUI 2011AA)
405824009 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patient has primary or secondary amyloidosis.
Item
Patient has primary or secondary amyloidosis.
boolean
C0268381 (UMLS CUI 2011AA)
23132008 (SNOMED CT 2011_0131)
10036673 (MedDRA 14.1)
C0221014 (UMLS CUI 2011AA)
281034005 (SNOMED CT 2011_0131)
10039811 (MedDRA 14.1)
E85.3 (ICD-10-CM Version 2010)
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