ID

28457

Beskrivning

Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64; ODM derived from: https://clinicaltrials.gov/show/NCT00488033

Länk

https://clinicaltrials.gov/show/NCT00488033

Nyckelord

Versioner (1)
  1. 2018-01-15 2018-01-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 januari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00488033

Engelsk

Eligibility Coronary Artery Disease NCT00488033

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age: males ≥ 50 years; females ≥55 years with: history of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin a1c > 6.5%), either type 1 or type 2, documented for at least 3 years and on medication for at least one year.
Beskrivning

Age | Gender | Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length | Glucose measurement, fasting | Glucohemoglobin measurement | Pharmacotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0011854
UMLS CUI [3,2]
C0872146
UMLS CUI [4,1]
C0011860
UMLS CUI [4,2]
C0872146
UMLS CUI [5]
C0202045
UMLS CUI [6]
C0202054
UMLS CUI [7]
C0013216
2. age: males ≥ 40 years; females ≥45 years with: history of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin a1c > 6.5%), either type 1 or type 2, documented for at least 5 years and on medication for at least one year.
Beskrivning

Age | Gender | Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length | Glucose measurement, fasting | Glucohemoglobin measurement | Pharmacotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0011854
UMLS CUI [3,2]
C0872146
UMLS CUI [4,1]
C0011860
UMLS CUI [4,2]
C0872146
UMLS CUI [5]
C0202045
UMLS CUI [6]
C0202054
UMLS CUI [7]
C0013216
3. the patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board.
Beskrivning

Informed Consent | Informed Consent Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known coronary artery disease (stenosis >70%, history of myocardial infarction, or angina)
Beskrivning

Coronary Artery Disease | Coronary Stenosis Percentage | Myocardial Infarction | Angina Pectoris

Datatyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2,1]
C0242231
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002962
2. symptomatic cerebral vascular disease (history of tia, cva, or cerebrovascular [carotid or cerebral arteries] revascularization)
Beskrivning

Cerebrovascular Disorder Symptomatic | Transient Ischemic Attack | Cerebrovascular accident | Revascularization Cerebrovascular | Carotid revascularisation | Cerebral Revascularization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007820
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0038454
UMLS CUI [4,1]
C0581603
UMLS CUI [4,2]
C1880018
UMLS CUI [5]
C3495793
UMLS CUI [6]
C0007794
3. symptomatic peripheral vascular disease (history of claudication, amputation, or peripheral [including renal arteries] arterial revascularization)
Beskrivning

Peripheral Vascular Disease Symptomatic | Claudication | Amputation | Peripheral revascularisation | Renal revascularisation surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C1456822
UMLS CUI [3]
C0002688
UMLS CUI [4]
C1096418
UMLS CUI [5]
C1095947
4. treatment with any other investigational drug within the previous 30 days
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
5. any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
Beskrivning

Therapeutic procedure At risk Patient | Condition At risk Patient | Therapeutic procedure Protocol Compliance Difficult | Condition Protocol Compliance Difficult

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0030705
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0332218
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0332218
6. pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. women of childbearing potential must be using adequate measures of contraception (as determined by the investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. women of childbearing potential must have a negative pregnancy test at screen.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking | Childbearing Potential Requirement Contraceptive methods | Childbearing Potential Requirement Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0700589
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0427780
7. any life threatening condition/significant co-morbidity such that primary screening is inappropriate.
Beskrivning

Condition Life Threatening Screening Inappropriate | Comorbidity Significant Screening Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C0220908
UMLS CUI [1,4]
C1548788
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0220908
UMLS CUI [2,4]
C1548788
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Similar models

Eligibility Coronary Artery Disease NCT00488033

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender | Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length | Glucose measurement, fasting | Glucohemoglobin measurement | Pharmacotherapy
Item
1. age: males ≥ 50 years; females ≥55 years with: history of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin a1c > 6.5%), either type 1 or type 2, documented for at least 3 years and on medication for at least one year.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0011854 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C0011860 (UMLS CUI [4,1])
C0872146 (UMLS CUI [4,2])
C0202045 (UMLS CUI [5])
C0202054 (UMLS CUI [6])
C0013216 (UMLS CUI [7])
Age | Gender | Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length | Glucose measurement, fasting | Glucohemoglobin measurement | Pharmacotherapy
Item
2. age: males ≥ 40 years; females ≥45 years with: history of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin a1c > 6.5%), either type 1 or type 2, documented for at least 5 years and on medication for at least one year.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0011854 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C0011860 (UMLS CUI [4,1])
C0872146 (UMLS CUI [4,2])
C0202045 (UMLS CUI [5])
C0202054 (UMLS CUI [6])
C0013216 (UMLS CUI [7])
Informed Consent | Informed Consent Patient Representative
Item
3. the patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Coronary Artery Disease | Coronary Stenosis Percentage | Myocardial Infarction | Angina Pectoris
Item
1. known coronary artery disease (stenosis >70%, history of myocardial infarction, or angina)
boolean
C1956346 (UMLS CUI [1])
C0242231 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
Cerebrovascular Disorder Symptomatic | Transient Ischemic Attack | Cerebrovascular accident | Revascularization Cerebrovascular | Carotid revascularisation | Cerebral Revascularization
Item
2. symptomatic cerebral vascular disease (history of tia, cva, or cerebrovascular [carotid or cerebral arteries] revascularization)
boolean
C0007820 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0007787 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0581603 (UMLS CUI [4,1])
C1880018 (UMLS CUI [4,2])
C3495793 (UMLS CUI [5])
C0007794 (UMLS CUI [6])
Peripheral Vascular Disease Symptomatic | Claudication | Amputation | Peripheral revascularisation | Renal revascularisation surgery
Item
3. symptomatic peripheral vascular disease (history of claudication, amputation, or peripheral [including renal arteries] arterial revascularization)
boolean
C0085096 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1456822 (UMLS CUI [2])
C0002688 (UMLS CUI [3])
C1096418 (UMLS CUI [4])
C1095947 (UMLS CUI [5])
Investigational New Drugs
Item
4. treatment with any other investigational drug within the previous 30 days
boolean
C0013230 (UMLS CUI [1])
Therapeutic procedure At risk Patient | Condition At risk Patient | Therapeutic procedure Protocol Compliance Difficult | Condition Protocol Compliance Difficult
Item
5. any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
boolean
C0087111 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0332218 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking | Childbearing Potential Requirement Contraceptive methods | Childbearing Potential Requirement Pregnancy test negative
Item
6. pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. women of childbearing potential must be using adequate measures of contraception (as determined by the investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. women of childbearing potential must have a negative pregnancy test at screen.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0427780 (UMLS CUI [5,3])
Condition Life Threatening Screening Inappropriate | Comorbidity Significant Screening Inappropriate
Item
7. any life threatening condition/significant co-morbidity such that primary screening is inappropriate.
boolean
C0348080 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0220908 (UMLS CUI [2,3])
C1548788 (UMLS CUI [2,4])
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