ID

28798

Beschreibung

Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study); ODM derived from: https://clinicaltrials.gov/show/NCT00664807

Link

https://clinicaltrials.gov/show/NCT00664807

Stichworte

Versionen (1)
  1. 05.02.18 05.02.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Februar 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Death, Sudden, Cardiac NCT00664807

Englisch

Eligibility Death, Sudden, Cardiac NCT00664807

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
the following criteria apply to all subjects:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subject has an icd or crt icd implanted
Beschreibung

Implantable cardioverter defibrillator insertion | CRT/ICD insertion

Datentyp

boolean

Alias
UMLS CUI [1]
C1868925
UMLS CUI [2]
C3805137
subject must be on optimal medical therapy
Beschreibung

Requirement Therapeutic procedure Optimal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C2698651
subject is a caucasian with all 4 grandparents believed to be caucasian
Beschreibung

Caucasians | Grandparents All Caucasians

Datentyp

boolean

Alias
UMLS CUI [1]
C0043157
UMLS CUI [2,1]
C0337471
UMLS CUI [2,2]
C0444868
UMLS CUI [2,3]
C0043157
subject has had a myocardial infarction (mi) prior to icd implantation
Beschreibung

Myocardial Infarction prior to Implantable cardioverter defibrillator insertion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C1868925
subject is willing and able to comply with the study protocol
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
subject is willing and able to sign and date the study informed consent and hipaa authorization (us)
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
case inclusion criteria:
Beschreibung

Case Subject Inclusion criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C1512693
the following criteria apply to case subjects only:
Beschreibung

Case Subject Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
subject is at least 40 years of age at time of icd implantation
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subject has at least one documented life-threatening arrhythmia (lta) on their icd that can transferred as a save-to-disk or has had an lta documented in their medical history. lta is defined as a true vt/vf episode with cycle length less than or equal to 400ms that was terminated by the device.
Beschreibung

Cardiac Arrhythmia Life Threatening Quantity Implantable defibrillator | Cardiac Arrhythmia Life Threatening Medical History | Ventricular Tachycardia Episode Cycle Length | Ventricular Fibrillation Episode Cycle Length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0162589
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C2826244
UMLS CUI [2,3]
C0262926
UMLS CUI [3,1]
C0042514
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1511572
UMLS CUI [3,4]
C1444754
UMLS CUI [4,1]
C0042510
UMLS CUI [4,2]
C0332189
UMLS CUI [4,3]
C1511572
UMLS CUI [4,4]
C1444754
control inclusion criteria:
Beschreibung

Inclusion criteria Control Group

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
the following criteria apply to control subjects only:
Beschreibung

Control Group Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
subject is currently at least 70 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subject has haad currently implanted medronic icd for a minimum of three years
Beschreibung

Implantable cardioverter defibrillator insertion Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868925
UMLS CUI [1,2]
C0205369
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following criteria apply to all subjects:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subject has received a bone marrow or heart transplant at any time
Beschreibung

Bone Marrow Transplantation | Heart Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C0018823
subject has a previously identified cause for arrhythmias (brugada, lqt, hcm)
Beschreibung

Cause Cardiac Arrhythmia | Brugada Syndrome | Long QT Syndrome | Hypertrophic Cardiomyopathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0003811
UMLS CUI [2]
C1142166
UMLS CUI [3]
C0023976
UMLS CUI [4]
C0007194
control exclusion criteria:
Beschreibung

Exclusion Criteria Control Group

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0009932
the following criteria apply to control subjects only:
Beschreibung

Control Group Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
subject has had a potentially lta documented on their icd
Beschreibung

Cardiac Arrhythmia Life Threatening potential Implantable defibrillator

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C3245505
UMLS CUI [1,4]
C0162589
subject was previously identified as having a ltd at any time in life
Beschreibung

Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C3846158
subject has had the memory on their icd cleared at any time in the past three years.
Beschreibung

Implantable defibrillator Memory Cleared

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C1706377
UMLS CUI [1,3]
C0521097
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Death, Sudden, Cardiac NCT00664807

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
the following criteria apply to all subjects:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Implantable cardioverter defibrillator insertion | CRT/ICD insertion
Item
subject has an icd or crt icd implanted
boolean
C1868925 (UMLS CUI [1])
C3805137 (UMLS CUI [2])
Requirement Therapeutic procedure Optimal
Item
subject must be on optimal medical therapy
boolean
C1514873 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C2698651 (UMLS CUI [1,3])
Caucasians | Grandparents All Caucasians
Item
subject is a caucasian with all 4 grandparents believed to be caucasian
boolean
C0043157 (UMLS CUI [1])
C0337471 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
C0043157 (UMLS CUI [2,3])
Myocardial Infarction prior to Implantable cardioverter defibrillator insertion
Item
subject has had a myocardial infarction (mi) prior to icd implantation
boolean
C0027051 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1868925 (UMLS CUI [1,3])
Protocol Compliance
Item
subject is willing and able to comply with the study protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
subject is willing and able to sign and date the study informed consent and hipaa authorization (us)
boolean
C0021430 (UMLS CUI [1])
Case Subject Inclusion criteria
Item
case inclusion criteria:
boolean
C1698493 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Case Subject Criteria Fulfill
Item
the following criteria apply to case subjects only:
boolean
C1698493 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Age
Item
subject is at least 40 years of age at time of icd implantation
boolean
C0001779 (UMLS CUI [1])
Cardiac Arrhythmia Life Threatening Quantity Implantable defibrillator | Cardiac Arrhythmia Life Threatening Medical History | Ventricular Tachycardia Episode Cycle Length | Ventricular Fibrillation Episode Cycle Length
Item
subject has at least one documented life-threatening arrhythmia (lta) on their icd that can transferred as a save-to-disk or has had an lta documented in their medical history. lta is defined as a true vt/vf episode with cycle length less than or equal to 400ms that was terminated by the device.
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0162589 (UMLS CUI [1,4])
C0003811 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C0042514 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1511572 (UMLS CUI [3,3])
C1444754 (UMLS CUI [3,4])
C0042510 (UMLS CUI [4,1])
C0332189 (UMLS CUI [4,2])
C1511572 (UMLS CUI [4,3])
C1444754 (UMLS CUI [4,4])
Inclusion criteria Control Group
Item
control inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Control Group Criteria Fulfill
Item
the following criteria apply to control subjects only:
boolean
C0009932 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Age
Item
subject is currently at least 70 years of age
boolean
C0001779 (UMLS CUI [1])
Implantable cardioverter defibrillator insertion Specified
Item
subject has haad currently implanted medronic icd for a minimum of three years
boolean
C1868925 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
the following criteria apply to all subjects:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Bone Marrow Transplantation | Heart Transplantation
Item
subject has received a bone marrow or heart transplant at any time
boolean
C0005961 (UMLS CUI [1])
C0018823 (UMLS CUI [2])
Cause Cardiac Arrhythmia | Brugada Syndrome | Long QT Syndrome | Hypertrophic Cardiomyopathy
Item
subject has a previously identified cause for arrhythmias (brugada, lqt, hcm)
boolean
C0015127 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
C1142166 (UMLS CUI [2])
C0023976 (UMLS CUI [3])
C0007194 (UMLS CUI [4])
Exclusion Criteria Control Group
Item
control exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Control Group Criteria Fulfill
Item
the following criteria apply to control subjects only:
boolean
C0009932 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Cardiac Arrhythmia Life Threatening potential Implantable defibrillator
Item
subject has had a potentially lta documented on their icd
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C3245505 (UMLS CUI [1,3])
C0162589 (UMLS CUI [1,4])
Other Coding
Item
subject was previously identified as having a ltd at any time in life
boolean
C3846158 (UMLS CUI [1])
Implantable defibrillator Memory Cleared
Item
subject has had the memory on their icd cleared at any time in the past three years.
boolean
C0162589 (UMLS CUI [1,1])
C1706377 (UMLS CUI [1,2])
C0521097 (UMLS CUI [1,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video