ID

20457

Beschreibung

Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention; ODM derived from: https://clinicaltrials.gov/show/NCT00611286

Link

https://clinicaltrials.gov/show/NCT00611286

Stichworte

Versionen (1)
  1. 23.02.17 23.02.17 -
Hochgeladen am

23. Februar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00611286

Englisch

Eligibility Coronary Artery Disease NCT00611286

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or females ≥ 18 years of age with coronary artery disease with low, intermediate or high-risk coronary anatomy, which is considered suitable for pci with stent placement.
Beschreibung

Age | Coronary Artery Disease | Anatomy Coronary Low Risk | Anatomy Coronary Intermediate Risk | Anatomy Coronary High risk | Percutaneous Coronary Intervention Amenable | Placement of stent Amenable

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1956346
UMLS CUI [3,1]
C1384516
UMLS CUI [3,2]
C1522318
UMLS CUI [3,3]
C3538919
UMLS CUI [4,1]
C1384516
UMLS CUI [4,2]
C1522318
UMLS CUI [4,3]
C3640764
UMLS CUI [5,1]
C1384516
UMLS CUI [5,2]
C1522318
UMLS CUI [5,3]
C0332167
UMLS CUI [6,1]
C1532338
UMLS CUI [6,2]
C3900053
UMLS CUI [7,1]
C0522776
UMLS CUI [7,2]
C3900053
2. subjects who have provided written informed consent prior to initiation of any study-related procedures, prior to receiving any pre-procedural sedation and who agree to comply with all protocol-specified procedures.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women who are pregnant. women of childbearing potential must have a negative pregnancy test (urine or serum hcg) within 7 days prior to randomization; as close to randomization as possible, within 24 hours preferred.
Beschreibung

Pregnancy | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test (B-HCG) Negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430060
UMLS CUI [3,3]
C1513916
2. allergy or intolerance to aspirin, or both clopidogrel and ticlopidine
Beschreibung

Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | aspirin intolerance | intolerance to clopidogrel | intolerance to Ticlopidine

Datentyp

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0040207
UMLS CUI [4]
C0004059
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0070166
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0040207
3. subjects with a contraindication to anticoagulation and/or increased bleeding risk:
Beschreibung

Medical contraindication Anticoagulation | Bleeding Risk Increased

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
UMLS CUI [2,1]
C3251812
UMLS CUI [2,2]
C0205217
past or present bleeding disorder including a history of the following within 1 month prior to randomization: clinically relevant gastrointestinal bleeding, gross (visible) hematuria,
Beschreibung

Blood Coagulation Disorders | Gastrointestinal Hemorrhage | Frank hematuria

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0017181
UMLS CUI [3]
C0473237
planned major surgery including cabg after or within 1 month prior to randomization.
Beschreibung

major surgery Planned | Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0010055
any subject with a known coagulopathy, platelet disorder, or history of thrombocytopenia.
Beschreibung

Blood Coagulation Disorders | Blood Platelet Disorders | Thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0005818
UMLS CUI [3]
C0040034
4. subjects with a history of cancer (limiting survival) not known to be disease free, with the exception of basal cell carcinoma of the skin.
Beschreibung

Malignant Neoplasms Continuance of life Limiting | Basal cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0038952
UMLS CUI [1,3]
C0439801
UMLS CUI [2]
C0007117
5. history of clinically important, recent or ongoing alcohol abuse or other drug abuse.
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
6. known platelet count <100,000/mm3 (<100 x 109/l).
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
7. subjects who is unable to give informed consent and assurance for complete contact through 2 years.
Beschreibung

Informed Consent Unable | Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00611286

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Coronary Artery Disease | Anatomy Coronary Low Risk | Anatomy Coronary Intermediate Risk | Anatomy Coronary High risk | Percutaneous Coronary Intervention Amenable | Placement of stent Amenable
Item
1. males or females ≥ 18 years of age with coronary artery disease with low, intermediate or high-risk coronary anatomy, which is considered suitable for pci with stent placement.
boolean
C0001779 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C1384516 (UMLS CUI [3,1])
C1522318 (UMLS CUI [3,2])
C3538919 (UMLS CUI [3,3])
C1384516 (UMLS CUI [4,1])
C1522318 (UMLS CUI [4,2])
C3640764 (UMLS CUI [4,3])
C1384516 (UMLS CUI [5,1])
C1522318 (UMLS CUI [5,2])
C0332167 (UMLS CUI [5,3])
C1532338 (UMLS CUI [6,1])
C3900053 (UMLS CUI [6,2])
C0522776 (UMLS CUI [7,1])
C3900053 (UMLS CUI [7,2])
Informed Consent | Protocol Compliance
Item
2. subjects who have provided written informed consent prior to initiation of any study-related procedures, prior to receiving any pre-procedural sedation and who agree to comply with all protocol-specified procedures.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
1. women who are pregnant. women of childbearing potential must have a negative pregnancy test (urine or serum hcg) within 7 days prior to randomization; as close to randomization as possible, within 24 hours preferred.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430060 (UMLS CUI [3,2])
C1513916 (UMLS CUI [3,3])
Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | aspirin intolerance | intolerance to clopidogrel | intolerance to Ticlopidine
Item
2. allergy or intolerance to aspirin, or both clopidogrel and ticlopidine
boolean
C0004058 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0040207 (UMLS CUI [3,2])
C0004059 (UMLS CUI [4])
C1744706 (UMLS CUI [5,1])
C0070166 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0040207 (UMLS CUI [6,2])
Medical contraindication Anticoagulation | Bleeding Risk Increased
Item
3. subjects with a contraindication to anticoagulation and/or increased bleeding risk:
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C3251812 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
Blood Coagulation Disorders | Gastrointestinal Hemorrhage | Frank hematuria
Item
past or present bleeding disorder including a history of the following within 1 month prior to randomization: clinically relevant gastrointestinal bleeding, gross (visible) hematuria,
boolean
C0005779 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0473237 (UMLS CUI [3])
major surgery Planned | Coronary Artery Bypass Surgery
Item
planned major surgery including cabg after or within 1 month prior to randomization.
boolean
C0679637 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0010055 (UMLS CUI [2])
Blood Coagulation Disorders | Blood Platelet Disorders | Thrombocytopenia
Item
any subject with a known coagulopathy, platelet disorder, or history of thrombocytopenia.
boolean
C0005779 (UMLS CUI [1])
C0005818 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
Malignant Neoplasms Continuance of life Limiting | Basal cell carcinoma
Item
4. subjects with a history of cancer (limiting survival) not known to be disease free, with the exception of basal cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1,1])
C0038952 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0007117 (UMLS CUI [2])
Substance Use Disorders
Item
5. history of clinically important, recent or ongoing alcohol abuse or other drug abuse.
boolean
C0038586 (UMLS CUI [1])
Platelet Count measurement
Item
6. known platelet count <100,000/mm3 (<100 x 109/l).
boolean
C0032181 (UMLS CUI [1])
Informed Consent Unable | Compliance behavior Limited
Item
7. subjects who is unable to give informed consent and assurance for complete contact through 2 years.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
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