ID

11710

Description

Through last couple of years the number of patients treated for acute coronary event without persistent ST segment elevation in ECG has been growing. This is probably an effect of improving diagnostics of myocardial infraction without persistent ST segment elevation in ECG, due to routine Troponin serum level evaluation and better primary prevention. This fact makes the search for the optimal treatment for patients with acute coronary event without persistent ST segment elevation in ECG, including both patients intended for pharmacological and invasive treatment percutaneous coronary intervention (PCI) or coronary artery byppass grafting (CABG). Patients undergoing invasive treatment for acute coronary event, have higher risk rate, than those with stabile angina pectoris. The authors of this study want to evaluate, whether the proportional use of platelet GP IIb/IIIa receptor antagonist - eptifibatide in patients undergoing CABG results in improvement of short-, and long time results in those patients. Eptifibatide ( Integrilin) a cyclic heptapeptide antagonist of the GP IIb/IIIa integrin receptor, is an intravenous antagonist with rapid onset and short half-life. https://clinicaltrials.gov/ct2/show/NCT01863134

Link

https://clinicaltrials.gov/ct2/show/NCT01863134

Keywords

Versions (1)
  1. 7/28/15 7/28/15 -
Uploaded on

July 28, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Eptifibatide Acute Coronary Syndrome NCT01863134

English

Eligibility criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility criteria
Inclusion Criteria
Description

Inclusion Criteria

Subjects must have a typical anginal pain lasting at least 20 min., but no longer than 24h.
Description

Subjects must have a typical anginal pain lasting at least 20 min., but no longer than 24h.

Data type

boolean

Alias
UMLS CUI-1
C0008031
ECG confirming ischaemia
Description

ECG confirming ischaemia

Data type

boolean

Alias
UMLS CUI-1
C1141959
ST segment depression >= 1,0 mm in at least 2 leads
Description

ST segment depression >= 1,0 mm in at least 2 leads

Data type

boolean

Alias
UMLS CUI-1
C0520887
negative T waves >= 2,0 mm in at least 2 leads
Description

negative T waves >= 2,0 mm in at least 2 leads

Data type

boolean

Alias
UMLS CUI-1
C0520888
Positive troponin I (TnI)
Description

Positive troponin I (TnI)

Data type

boolean

Alias
UMLS CUI-1
C0920210
Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent.
Description

Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent.

Data type

boolean

Alias
UMLS CUI-1
C0021430
Subjects must be ≥ 21 year of age, of either sex and any race.
Description

Subjects must be ≥ 21 year of age, of either sex and any race.

Data type

boolean

Alias
UMLS CUI-1
C0001779
Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD - intrauterine device, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
Description

Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD - intrauterine device, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).

Data type

boolean

Alias
UMLS CUI-1
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Women who are pregnant or nursing.
Description

Women who are pregnant or nursing.

Data type

boolean

Alias
UMLS CUI-1
C0549206
Angina lasting longer than 24h
Description

Angina lasting longer than 24h

Data type

boolean

Alias
UMLS CUI-1
C0002962
ST segment elevation - Pardy wave
Description

ST segment elevation - Pardy wave

Data type

boolean

Alias
UMLS CUI-1
C0520886
age over 75 years
Description

age over 75 years

Data type

boolean

Alias
UMLS CUI-1
C0001779
history of revascularization procedure during last 6 months (PTCA, CABG)
Description

history of revascularization procedure during last 6 months (PTCA, CABG)

Data type

boolean

Alias
UMLS CUI-1
C0027056
chronic heart failure (NYHA III or IV) during pre-hospitalization period
Description

chronic heart failure (NYHA III or IV) during pre-hospitalization period

Data type

boolean

Alias
UMLS CUI-1
C0018802
History of bleeding from gastrointestinal tract system during last 30 days
Description

History of bleeding from gastrointestinal tract system during last 30 days

Data type

boolean

Alias
UMLS CUI-1
C0017181
History of bleeding from genitourinary system during last 30 days
Description

History of bleeding from genitourinary system during last 30 days

Data type

boolean

Alias
UMLS CUI-1
C0919591
history of intracranial lesions or stroke
Description

history of intracranial lesions or stroke

Data type

boolean

Alias
UMLS CUI-1
C0559159
history of major surgery during last 6 weeks
Description

history of major surgery during last 6 weeks

Data type

boolean

Alias
UMLS CUI-1
C0679637
history of trauma during last 6 weeks
Description

history of trauma during last 6 weeks

Data type

boolean

Alias
UMLS CUI-1
C3714660
history of hemorrhagic diathesis
Description

history of hemorrhagic diathesis

Data type

boolean

Alias
UMLS CUI-1
C3251812
thrombocytopenia < 100 000/mm3
Description

thrombocytopenia < 100 000/mm3

Data type

boolean

Alias
UMLS CUI-1
C0040034
anticoagulant therapy with INR>2,0
Description

anticoagulant therapy with INR>2,0

Data type

boolean

Alias
UMLS CUI-1
C0003280
significant hepatic failure
Description

significant hepatic failure

Data type

boolean

Alias
UMLS CUI-1
C0085605
significant renal failure with serum creatinine>2,0 mg%
Description

significant renal failure with serum creatinine>2,0 mg%

Data type

boolean

Alias
UMLS CUI-1
C0035078
elevated blood pressure: SBP>200mmHg and/or DBP>110mmHg despite the antihypertensive treatment
Description

elevated blood pressure: SBP>200mmHg and/or DBP>110mmHg despite the antihypertensive treatment

Data type

boolean

Alias
UMLS CUI-1
C0020538
allergy to drugs or any therapeutic agent
Description

allergy to drugs or any therapeutic agent

Data type

boolean

Alias
UMLS CUI-1
C0013182
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Similar models

Eligibility criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Chest pain
Item
Subjects must have a typical anginal pain lasting at least 20 min., but no longer than 24h.
boolean
C0008031 (UMLS CUI-1)
ECG signs of myocardial ischaemia
Item
ECG confirming ischaemia
boolean
C1141959 (UMLS CUI-1)
ST-segment depression
Item
ST segment depression >= 1,0 mm in at least 2 leads
boolean
C0520887 (UMLS CUI-1)
Inverted T wave
Item
negative T waves >= 2,0 mm in at least 2 leads
boolean
C0520888 (UMLS CUI-1)
Troponin I
Item
Positive troponin I (TnI)
boolean
C0920210 (UMLS CUI-1)
Informed consent
Item
Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent.
boolean
C0021430 (UMLS CUI-1)
Age
Item
Subjects must be ≥ 21 year of age, of either sex and any race.
boolean
C0001779 (UMLS CUI-1)
Contraception
Item
Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD - intrauterine device, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
boolean
C0700589 (UMLS CUI-1)
Item Group
Exclusion Criteria
Pregnancy
Item
Women who are pregnant or nursing.
boolean
C0549206 (UMLS CUI-1)
Angina pectoris
Item
Angina lasting longer than 24h
boolean
C0002962 (UMLS CUI-1)
ST-segment elevation
Item
ST segment elevation - Pardy wave
boolean
C0520886 (UMLS CUI-1)
Age
Item
age over 75 years
boolean
C0001779 (UMLS CUI-1)
Myocardial Revascularization
Item
history of revascularization procedure during last 6 months (PTCA, CABG)
boolean
C0027056 (UMLS CUI-1)
Congestive heart failure
Item
chronic heart failure (NYHA III or IV) during pre-hospitalization period
boolean
C0018802 (UMLS CUI-1)
Gastrointestinal Hemorrhage
Item
History of bleeding from gastrointestinal tract system during last 30 days
boolean
C0017181 (UMLS CUI-1)
Urogenital hemorrhage
Item
History of bleeding from genitourinary system during last 30 days
boolean
C0919591 (UMLS CUI-1)
History of stroke
Item
history of intracranial lesions or stroke
boolean
C0559159 (UMLS CUI-1)
Major surgery
Item
history of major surgery during last 6 weeks
boolean
C0679637 (UMLS CUI-1)
Trauma
Item
history of trauma during last 6 weeks
boolean
C3714660 (UMLS CUI-1)
Bleeding risk
Item
history of hemorrhagic diathesis
boolean
C3251812 (UMLS CUI-1)
Thrombocytopenia
Item
thrombocytopenia < 100 000/mm3
boolean
C0040034 (UMLS CUI-1)
Anticoagulants
Item
anticoagulant therapy with INR>2,0
boolean
C0003280 (UMLS CUI-1)
Liver failure
Item
significant hepatic failure
boolean
C0085605 (UMLS CUI-1)
Kidney failure
Item
significant renal failure with serum creatinine>2,0 mg%
boolean
C0035078 (UMLS CUI-1)
Hypertension
Item
elevated blood pressure: SBP>200mmHg and/or DBP>110mmHg despite the antihypertensive treatment
boolean
C0020538 (UMLS CUI-1)
Medication allergy
Item
allergy to drugs or any therapeutic agent
boolean
C0013182 (UMLS CUI-1)
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