Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
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
Ausschlusskriterien
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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