ID

44478

Beskrivning

Reduced Dose of Unfractionated Heparin in Patients Undergoing PCI; ODM derived from: https://clinicaltrials.gov/show/NCT00735280

Länk

https://clinicaltrials.gov/show/NCT00735280

Nyckelord

Versioner (2)
  1. 2018-01-19 2018-01-19 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00735280

Engelsk

Eligibility Coronary Artery Disease NCT00735280

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients older than 18 years undergoing a pci procedure
Beskrivning

Age | Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1532338
2. pretreatment with 600mg clopidogrel at least 2 hours before the intervention
Beskrivning

Pretreatment Intervention | Clopidogrel Dosage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3539076
UMLS CUI [1,2]
C0184661
UMLS CUI [2,1]
C0070166
UMLS CUI [2,2]
C0178602
3. informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
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. recent st-elevation myocardial infarction within the last 48 hours
Beskrivning

ST segment elevation myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C1536220
2. acute coronary syndromes with positive biomarkers (troponin t > 0.03 μg/l or ck-mb > uln)
Beskrivning

Acute Coronary Syndrome | Biological Markers Positive | Troponin T Assay | Creatine kinase MB measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C1141947
UMLS CUI [4]
C0523584
3. cardiogenic shock
Beskrivning

Shock, Cardiogenic

Datatyp

boolean

Alias
UMLS CUI [1]
C0036980
4. malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance
Beskrivning

Malignant Neoplasms Protocol Compliance Lacking | Life Expectancy | Comorbidity Protocol Compliance Lacking | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0332268
UMLS CUI [2]
C0023671
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0332268
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0030286
UMLS CUI [6,2]
C0205082
5. active bleeding; bleeding diathesis
Beskrivning

Hemorrhage | Bleeding tendency

Datatyp

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C1458140
6. history of gastrointestinal or genitourinary bleeding within the last 6 weeks
Beskrivning

Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2]
C0919591
7. presence of diseases which have a high probability of vascular lesions and subsequent bleeding such as active gastric ulcer or active ulcerous colitis
Beskrivning

Disease Probability High Vascular lesions | Disease Probability High Hemorrhage | Gastric ulcer | Ulcerative Colitis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0033204
UMLS CUI [1,3]
C0205250
UMLS CUI [1,4]
C1402315
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0033204
UMLS CUI [2,3]
C0205250
UMLS CUI [2,4]
C0019080
UMLS CUI [3]
C0038358
UMLS CUI [4]
C0009324
8. recent trauma or major surgery in the last month
Beskrivning

Trauma | Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C3714660
UMLS CUI [2]
C0679637
9. ophthalmic surgery or brain surgery in the last month
Beskrivning

Ophthalmologic Surgical Procedures | Operation on brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0038901
UMLS CUI [2]
C0195775
10. retinopathies or vitreous body bleeding in the last month
Beskrivning

Retinal Diseases | Vitreous Hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C0035309
UMLS CUI [2]
C0042909
11. history of intracranial bleeding or structural abnormalities (for example aneurysm of cerebral arteries)
Beskrivning

Intracranial Hemorrhage | Abnormality structural | Cerebral arterial aneurysm

Datatyp

boolean

Alias
UMLS CUI [1]
C0151699
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0678594
UMLS CUI [3]
C1290398
12. suspected aortic dissection; pericarditis and subacute bacterial endocarditis
Beskrivning

Dissection of aorta Suspected | Pericarditis | Subacute Bacterial Endocarditis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0340643
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C0031046
UMLS CUI [3]
C0014122
13. patient's refusal to blood transfusion.
Beskrivning

Blood Transfusion Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C1705116
14. oral anticoagulation therapy with coumarin derivative within the last 7 days
Beskrivning

Anticoagulation Therapy Oral | Coumadin Derivative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0699129
UMLS CUI [2,2]
C1527240
15. treatment with ufh within 6 hours unless an act is less than 150 sec or low-molecular weight heparin within 8 hours before enrollment
Beskrivning

Unfractionated Heparin | Exception Activated clotting time measurement | Heparin, Low-Molecular-Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C2825026
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0427611
UMLS CUI [3]
C0019139
16. treatment with bivalirudin within 24 hours before enrollment
Beskrivning

bivalirudin

Datatyp

boolean

Alias
UMLS CUI [1]
C0168273
17. severe uncontrolled hypertension >180/110 mmhg unresponsive to therapy
Beskrivning

Uncontrolled hypertension Severe Unresponsive to Treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205269
18. planned staged pci procedure within 30 days from index procedure or prior pci within the last 30 days.
Beskrivning

Staged Percutaneous Coronary Intervention Planned | Percutaneous Coronary Intervention Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3272260
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C0332185
19. relevant hematologic deviations: hemoglobin < 100 g/l, platelet count < 100 x 109 /l.
Beskrivning

Hematology finding abnormal | Hemoglobin measurement | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0475182
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
20. glomerular filtration rate (gfr) < 30 ml/min or serum creatinine > 30 mg/l or dependence on renal dialysis.
Beskrivning

Glomerular Filtration Rate | Creatinine measurement, serum | Dependence on renal dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0017654
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0524376
21. known allergy to the study medications: aspirin, clopidogrel, ufh, true anaphylaxis after prior exposure to contrast media.
Beskrivning

Hypersensitivity Investigational New Drugs | Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Unfractionated Heparin | Anaphylaxis Post Exposure to Contrast Media

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2]
C0004058
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C2825026
UMLS CUI [5,1]
C0002792
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C0332157
UMLS CUI [5,4]
C0009924
22. known heparin-induced thrombocytopenia (typ ii)
Beskrivning

Heparin-induced thrombocytopenia type II

Datatyp

boolean

Alias
UMLS CUI [1]
C0272275
23. previous enrollment in this trial.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
24. pregnancy (present, suspected or planned) or positive pregnancy test.
Beskrivning

Pregnancy | Pregnancy Suspected | Pregnancy, Planned | Pregnancy test positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0240802
25. spinal, peridural and epidural anesthesia
Beskrivning

Spinal Anesthesia | Peridural Anesthesia

Datatyp

boolean

Alias
UMLS CUI [1]
C0002928
UMLS CUI [2]
C0002913
26. patient's inability to fully cooperate with the study protocol.
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Coronary Artery Disease NCT00735280

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Percutaneous Coronary Intervention
Item
1. patients older than 18 years undergoing a pci procedure
boolean
C0001779 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
Pretreatment Intervention | Clopidogrel Dosage
Item
2. pretreatment with 600mg clopidogrel at least 2 hours before the intervention
boolean
C3539076 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0070166 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Informed Consent | Informed Consent Patient Representative
Item
3. informed, written consent by the patient or her/his legally-authorized representative for participation in the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
ST segment elevation myocardial infarction
Item
1. recent st-elevation myocardial infarction within the last 48 hours
boolean
C1536220 (UMLS CUI [1])
Acute Coronary Syndrome | Biological Markers Positive | Troponin T Assay | Creatine kinase MB measurement
Item
2. acute coronary syndromes with positive biomarkers (troponin t > 0.03 μg/l or ck-mb > uln)
boolean
C0948089 (UMLS CUI [1])
C0005516 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1141947 (UMLS CUI [3])
C0523584 (UMLS CUI [4])
Shock, Cardiogenic
Item
3. cardiogenic shock
boolean
C0036980 (UMLS CUI [1])
Malignant Neoplasms Protocol Compliance Lacking | Life Expectancy | Comorbidity Protocol Compliance Lacking | Liver disease Severe | Kidney Disease Severe | Pancreatic Disease Severe
Item
4. malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than one year or that may result in protocol non-compliance
boolean
C0006826 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0023671 (UMLS CUI [2])
C0009488 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C0023895 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0030286 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
Hemorrhage | Bleeding tendency
Item
5. active bleeding; bleeding diathesis
boolean
C0019080 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage
Item
6. history of gastrointestinal or genitourinary bleeding within the last 6 weeks
boolean
C0017181 (UMLS CUI [1])
C0919591 (UMLS CUI [2])
Disease Probability High Vascular lesions | Disease Probability High Hemorrhage | Gastric ulcer | Ulcerative Colitis
Item
7. presence of diseases which have a high probability of vascular lesions and subsequent bleeding such as active gastric ulcer or active ulcerous colitis
boolean
C0012634 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
C1402315 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0205250 (UMLS CUI [2,3])
C0019080 (UMLS CUI [2,4])
C0038358 (UMLS CUI [3])
C0009324 (UMLS CUI [4])
Trauma | Major surgery
Item
8. recent trauma or major surgery in the last month
boolean
C3714660 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
Ophthalmologic Surgical Procedures | Operation on brain
Item
9. ophthalmic surgery or brain surgery in the last month
boolean
C0038901 (UMLS CUI [1])
C0195775 (UMLS CUI [2])
Retinal Diseases | Vitreous Hemorrhage
Item
10. retinopathies or vitreous body bleeding in the last month
boolean
C0035309 (UMLS CUI [1])
C0042909 (UMLS CUI [2])
Intracranial Hemorrhage | Abnormality structural | Cerebral arterial aneurysm
Item
11. history of intracranial bleeding or structural abnormalities (for example aneurysm of cerebral arteries)
boolean
C0151699 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0678594 (UMLS CUI [2,2])
C1290398 (UMLS CUI [3])
Dissection of aorta Suspected | Pericarditis | Subacute Bacterial Endocarditis
Item
12. suspected aortic dissection; pericarditis and subacute bacterial endocarditis
boolean
C0340643 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0031046 (UMLS CUI [2])
C0014122 (UMLS CUI [3])
Blood Transfusion Refused
Item
13. patient's refusal to blood transfusion.
boolean
C0005841 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Anticoagulation Therapy Oral | Coumadin Derivative
Item
14. oral anticoagulation therapy with coumarin derivative within the last 7 days
boolean
C0003281 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0699129 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
Unfractionated Heparin | Exception Activated clotting time measurement | Heparin, Low-Molecular-Weight
Item
15. treatment with ufh within 6 hours unless an act is less than 150 sec or low-molecular weight heparin within 8 hours before enrollment
boolean
C2825026 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0427611 (UMLS CUI [2,2])
C0019139 (UMLS CUI [3])
bivalirudin
Item
16. treatment with bivalirudin within 24 hours before enrollment
boolean
C0168273 (UMLS CUI [1])
Uncontrolled hypertension Severe Unresponsive to Treatment
Item
17. severe uncontrolled hypertension >180/110 mmhg unresponsive to therapy
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Staged Percutaneous Coronary Intervention Planned | Percutaneous Coronary Intervention Recent
Item
18. planned staged pci procedure within 30 days from index procedure or prior pci within the last 30 days.
boolean
C3272260 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1532338 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Hematology finding abnormal | Hemoglobin measurement | Platelet Count measurement
Item
19. relevant hematologic deviations: hemoglobin < 100 g/l, platelet count < 100 x 109 /l.
boolean
C0475182 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Glomerular Filtration Rate | Creatinine measurement, serum | Dependence on renal dialysis
Item
20. glomerular filtration rate (gfr) < 30 ml/min or serum creatinine > 30 mg/l or dependence on renal dialysis.
boolean
C0017654 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0524376 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Unfractionated Heparin | Anaphylaxis Post Exposure to Contrast Media
Item
21. known allergy to the study medications: aspirin, clopidogrel, ufh, true anaphylaxis after prior exposure to contrast media.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0004058 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C2825026 (UMLS CUI [4,2])
C0002792 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0332157 (UMLS CUI [5,3])
C0009924 (UMLS CUI [5,4])
Heparin-induced thrombocytopenia type II
Item
22. known heparin-induced thrombocytopenia (typ ii)
boolean
C0272275 (UMLS CUI [1])
Study Subject Participation Status
Item
23. previous enrollment in this trial.
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Pregnancy Suspected | Pregnancy, Planned | Pregnancy test positive
Item
24. pregnancy (present, suspected or planned) or positive pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
Spinal Anesthesia | Peridural Anesthesia
Item
25. spinal, peridural and epidural anesthesia
boolean
C0002928 (UMLS CUI [1])
C0002913 (UMLS CUI [2])
Protocol Compliance Unable
Item
26. patient's inability to fully cooperate with the study protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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