ID

35518

Beschreibung

Multicenter Randomized Comparison of Early Vascular Responses Between Everolimus-eluting Cobalt-chromium Stent and Identically Designed Bare-Metal Stent in Patients With Acute Myocardial Infarction; ODM derived from: https://clinicaltrials.gov/show/NCT02014753

Link

https://clinicaltrials.gov/show/NCT02014753

Stichworte

Versionen (1)
  1. 07.03.19 07.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02014753

Englisch

Eligibility Coronary Artery Disease NCT02014753

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ami definition is accordance with the third universal definition of esc /accf/ aha/
Beschreibung

Acute myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0155626
whf task force10, detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (ctn) i or t] with at least one value above the 99th percentile upper reference limit (url) and with at least one of the following:
Beschreibung

Cardiac biomarkers Measurement | Cardiac troponin I measurement | Cardiac troponin T measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2735102
UMLS CUI [1,2]
C0242485
UMLS CUI [2]
C0883409
UMLS CUI [3]
C0523953
symptoms of ischemia.
Beschreibung

Symptoms Ischemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0022116
new or presumed new significant st-segment-t wave (st-t) changes or new left bundle branch block (lbbb).
Beschreibung

ST-T segment Change | New LBBB

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0489650
UMLS CUI [1,2]
C0392747
UMLS CUI [2]
C3844356
development of pathological q waves in the ecg. imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
Beschreibung

Pathological Q wave Electrocardiography | New Loss of Viable Myocardium by Imaging | New Regional Wall Motion Abnormality by Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0429090
UMLS CUI [1,2]
C1623258
UMLS CUI [2]
C3898142
UMLS CUI [3]
C3898140
identification of an intracoronary thrombus by angiography or autopsy
Beschreibung

Thrombus Coronary Angiography | Thrombus Coronary Autopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C1522318
UMLS CUI [1,3]
C0002978
UMLS CUI [2,1]
C0087086
UMLS CUI [2,2]
C1522318
UMLS CUI [2,3]
C0004398
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
shock
Beschreibung

Shock

Datentyp

boolean

Alias
UMLS CUI [1]
C0036974
patients who are judged incapable of undergoing clinical follow-up 12 months after pci (consider also the location of patients' residences)
Beschreibung

Follow-up Unable | Status post Percutaneous Coronary Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1532338
lack of specific findings of acs by angiography (left to the operator's decision.)
Beschreibung

Acute Coronary Syndrome Absent Angiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948089
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0002978
the culprit lesion is the left main coronary trunk
Beschreibung

Culprit lesion Trunk of left coronary artery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299364
UMLS CUI [1,2]
C0920980
lesion with the reference vascular diameter less than 2.0mm or not less than 4.5mm by visual evaluation.
Beschreibung

Lesion | Reference Diameter Vascular

Datentyp

boolean

Alias
UMLS CUI [1]
C0221198
UMLS CUI [2,1]
C1706462
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C1801960
chronic renal failure with serum creatinine level not less than 2.0mg/dl on hospital visit
Beschreibung

Kidney Failure, Chronic | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0201976
patients on hemodialysis cancer patients whose vital prognosis is expected to be within 2 years. surgery that requires discontinuation of the antiplatelet agent is scheduled within 3 months
Beschreibung

Hemodialysis | Malignant Neoplasms | Life Expectancy | Operative Surgical Procedures Scheduled | Requirement Antiplatelet Agents Discontinuation

Datentyp

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0023671
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0205539
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0085826
UMLS CUI [5,3]
C1444662
patients who experienced adverse reaction to aspirin or clopidogrel (this shall not apply for patients in whom safety of ticlopidine is confirmed)
Beschreibung

Aspirin adverse reaction | Adverse reaction to clopidogrel

Datentyp

boolean

Alias
UMLS CUI [1]
C0413696
UMLS CUI [2]
C1689910
patients who took warfarin before the onset
Beschreibung

Warfarin

Datentyp

boolean

Alias
UMLS CUI [1]
C0043031
patients under 20 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
pregnant women
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
ami due to stent thrombosis at prior stented segment.
Beschreibung

Acute myocardial infarction Due to Stent thrombosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155626
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3897493
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT02014753

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Acute myocardial infarction
Item
ami definition is accordance with the third universal definition of esc /accf/ aha/
boolean
C0155626 (UMLS CUI [1])
Cardiac biomarkers Measurement | Cardiac troponin I measurement | Cardiac troponin T measurement
Item
whf task force10, detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (ctn) i or t] with at least one value above the 99th percentile upper reference limit (url) and with at least one of the following:
boolean
C2735102 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0883409 (UMLS CUI [2])
C0523953 (UMLS CUI [3])
Symptoms Ischemia
Item
symptoms of ischemia.
boolean
C1457887 (UMLS CUI [1,1])
C0022116 (UMLS CUI [1,2])
ST-T segment Change | New LBBB
Item
new or presumed new significant st-segment-t wave (st-t) changes or new left bundle branch block (lbbb).
boolean
C0489650 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C3844356 (UMLS CUI [2])
Pathological Q wave Electrocardiography | New Loss of Viable Myocardium by Imaging | New Regional Wall Motion Abnormality by Imaging
Item
development of pathological q waves in the ecg. imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
boolean
C0429090 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C3898142 (UMLS CUI [2])
C3898140 (UMLS CUI [3])
Thrombus Coronary Angiography | Thrombus Coronary Autopsy
Item
identification of an intracoronary thrombus by angiography or autopsy
boolean
C0087086 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0002978 (UMLS CUI [1,3])
C0087086 (UMLS CUI [2,1])
C1522318 (UMLS CUI [2,2])
C0004398 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Shock
Item
shock
boolean
C0036974 (UMLS CUI [1])
Follow-up Unable | Status post Percutaneous Coronary Intervention
Item
patients who are judged incapable of undergoing clinical follow-up 12 months after pci (consider also the location of patients' residences)
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1532338 (UMLS CUI [2,2])
Acute Coronary Syndrome Absent Angiography
Item
lack of specific findings of acs by angiography (left to the operator's decision.)
boolean
C0948089 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0002978 (UMLS CUI [1,3])
Culprit lesion Trunk of left coronary artery
Item
the culprit lesion is the left main coronary trunk
boolean
C1299364 (UMLS CUI [1,1])
C0920980 (UMLS CUI [1,2])
Lesion | Reference Diameter Vascular
Item
lesion with the reference vascular diameter less than 2.0mm or not less than 4.5mm by visual evaluation.
boolean
C0221198 (UMLS CUI [1])
C1706462 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C1801960 (UMLS CUI [2,3])
Kidney Failure, Chronic | Creatinine measurement, serum
Item
chronic renal failure with serum creatinine level not less than 2.0mg/dl on hospital visit
boolean
C0022661 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Hemodialysis | Malignant Neoplasms | Life Expectancy | Operative Surgical Procedures Scheduled | Requirement Antiplatelet Agents Discontinuation
Item
patients on hemodialysis cancer patients whose vital prognosis is expected to be within 2 years. surgery that requires discontinuation of the antiplatelet agent is scheduled within 3 months
boolean
C0019004 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C0085826 (UMLS CUI [5,2])
C1444662 (UMLS CUI [5,3])
Aspirin adverse reaction | Adverse reaction to clopidogrel
Item
patients who experienced adverse reaction to aspirin or clopidogrel (this shall not apply for patients in whom safety of ticlopidine is confirmed)
boolean
C0413696 (UMLS CUI [1])
C1689910 (UMLS CUI [2])
Warfarin
Item
patients who took warfarin before the onset
boolean
C0043031 (UMLS CUI [1])
Age
Item
patients under 20 years old
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Acute myocardial infarction Due to Stent thrombosis
Item
ami due to stent thrombosis at prior stented segment.
boolean
C0155626 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3897493 (UMLS CUI [1,3])
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