ID

35571

Beschreibung

Delayed Plaque Morphology in Patients With STEMI After Thrombus Aspiration During Primary PCI; ODM derived from: https://clinicaltrials.gov/show/NCT02384824

Link

https://clinicaltrials.gov/show/NCT02384824

Stichworte

Versionen (1)
  1. 10.03.19 10.03.19 -
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See clinicaltrials.gov

Hochgeladen am

10. März 2019

DOI

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Eligibility Coronary Artery Disease NCT02384824

Englisch

Eligibility Coronary Artery Disease NCT02384824

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. clinical inclusion criteria:
Beschreibung

Inclusion criteria Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205210
age > 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
onset of stemi > 30 minutes, but < 12 hours
Beschreibung

Onset of STEMI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C1536220
st segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed lbbb on ecg
Beschreibung

ST segment elevation Leads Quantity | Left Bundle-Branch Block New ECG

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0520886
UMLS CUI [1,2]
C0181586
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0023211
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C0013798
willing and able to provide informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. angiographic inclusion criteria:
Beschreibung

Inclusion criteria Angiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0002978
having at least one infarct-related coronary artery, of which
Beschreibung

Coronary artery Relationship Infarct Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205042
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0021308
UMLS CUI [1,4]
C1265611
the culprit lesion is suitable for stenting;
Beschreibung

Culprit lesion suitable Stenting

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299364
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C2348535
the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm;
Beschreibung

Culprit Vessel | Reference Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299364
UMLS CUI [1,2]
C0005847
UMLS CUI [2,1]
C1706462
UMLS CUI [2,2]
C1301886
the timi flow is ≤ 1 in culprit lesion segment prior to guide wire crossing
Beschreibung

TIMI Flow Culprit lesion segment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3272266
UMLS CUI [1,2]
C1299364
UMLS CUI [1,3]
C0441635
no excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
Beschreibung

Culprit lesion segment | Tortuosity Excessive Absent | Calcification Excessive Absent | Stent allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299364
UMLS CUI [1,2]
C0441635
UMLS CUI [2,1]
C0333076
UMLS CUI [2,2]
C0442802
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0175895
UMLS CUI [3,2]
C0442802
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0038257
UMLS CUI [4,2]
C0683607
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinical exclusion criteria:
Beschreibung

Exclusion Criteria Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205210
1. contraindicating to any concomitant study medications
Beschreibung

Medical contraindication Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
2. having cardiogenic shock with hemodynamic instability
Beschreibung

Shock, Cardiogenic | Hemodynamic instability

Datentyp

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2]
C0948268
3. a history of bleeding diathesis or known coagulopathy
Beschreibung

Bleeding tendency | Blood Coagulation Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
4. a history of cerebrovascular accident (cva) or transient ischemic attack (tia) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (gi) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count < 100,000 /mm3 or hb < 10 g/dl
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack | Neoplasms, Intracranial | Intracranial Aneurysm | Intracranial Arteriovenous Malformation | Peptic Ulcer | Gastrointestinal Hemorrhage | Procedure Major Planned | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3]
C1527390
UMLS CUI [4]
C0007766
UMLS CUI [5]
C0007772
UMLS CUI [6]
C0030920
UMLS CUI [7]
C0017181
UMLS CUI [8,1]
C0184661
UMLS CUI [8,2]
C0205164
UMLS CUI [8,3]
C1301732
UMLS CUI [9]
C0032181
UMLS CUI [10]
C0518015
5. planned surgery which may cause discontinuation of adp-receptor antagonist
Beschreibung

Operative Surgical Procedures Planned | ADP Receptor Inhibitors Discontinuation Possible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1373149
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0332149
6. other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year
Beschreibung

Illness Serious | Malignant Neoplasms | Reduced life expectancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0006826
UMLS CUI [3]
C1858274
7. repeated mi within 7 days of hospitalization for acute mi
Beschreibung

Myocardial Infarction Repeated | Hospitalization Acute myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205341
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0155626
angiographic exclusion criteria:
Beschreibung

Exclusion Criteria Angiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0002978
bifurcated lesion unable to identify the culprit lesion
Beschreibung

Bifurcation lesion | Culprit lesion Identification Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C1299363
UMLS CUI [2,1]
C1299364
UMLS CUI [2,2]
C0205396
UMLS CUI [2,3]
C1299582
the culprit lesion is located in the left main artery
Beschreibung

Culprit lesion Location Left coronary artery main stem

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299364
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0226031
diffusive lesions without distinguishable culprit lesion
Beschreibung

Diffuse Lesion | Culprit lesion Determination Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C1707743
UMLS CUI [2,1]
C1299364
UMLS CUI [2,2]
C1148554
UMLS CUI [2,3]
C1299582
previous stent implantation in the culprit lesion segment or stemi caused by stent thrombosis
Beschreibung

Placement of stent Culprit lesion segment | STEMI caused by Stent thrombosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522776
UMLS CUI [1,2]
C1299364
UMLS CUI [1,3]
C0441635
UMLS CUI [2,1]
C1536220
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C3897493
likely cabg procedure within 30 days
Beschreibung

Coronary Artery Bypass Surgery Probably

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C0750492
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT02384824

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Clinical
Item
1. clinical inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Onset of STEMI
Item
onset of stemi > 30 minutes, but < 12 hours
boolean
C0332162 (UMLS CUI [1,1])
C1536220 (UMLS CUI [1,2])
ST segment elevation Leads Quantity | Left Bundle-Branch Block New ECG
Item
st segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed lbbb on ecg
boolean
C0520886 (UMLS CUI [1,1])
C0181586 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0023211 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0013798 (UMLS CUI [2,3])
Informed Consent
Item
willing and able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Inclusion criteria Angiography
Item
2. angiographic inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Coronary artery Relationship Infarct Quantity
Item
having at least one infarct-related coronary artery, of which
boolean
C0205042 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0021308 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Culprit lesion suitable Stenting
Item
the culprit lesion is suitable for stenting;
boolean
C1299364 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C2348535 (UMLS CUI [1,3])
Culprit Vessel | Reference Diameter
Item
the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm;
boolean
C1299364 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1706462 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
TIMI Flow Culprit lesion segment
Item
the timi flow is ≤ 1 in culprit lesion segment prior to guide wire crossing
boolean
C3272266 (UMLS CUI [1,1])
C1299364 (UMLS CUI [1,2])
C0441635 (UMLS CUI [1,3])
Culprit lesion segment | Tortuosity Excessive Absent | Calcification Excessive Absent | Stent allowed
Item
no excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
boolean
C1299364 (UMLS CUI [1,1])
C0441635 (UMLS CUI [1,2])
C0333076 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0175895 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0038257 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Clinical
Item
1. clinical exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Medical contraindication Investigational New Drugs
Item
1. contraindicating to any concomitant study medications
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Shock, Cardiogenic | Hemodynamic instability
Item
2. having cardiogenic shock with hemodynamic instability
boolean
C0036980 (UMLS CUI [1])
C0948268 (UMLS CUI [2])
Bleeding tendency | Blood Coagulation Disorders
Item
3. a history of bleeding diathesis or known coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Cerebrovascular accident | Transient Ischemic Attack | Neoplasms, Intracranial | Intracranial Aneurysm | Intracranial Arteriovenous Malformation | Peptic Ulcer | Gastrointestinal Hemorrhage | Procedure Major Planned | Platelet Count measurement | Hemoglobin measurement
Item
4. a history of cerebrovascular accident (cva) or transient ischemic attack (tia) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (gi) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count < 100,000 /mm3 or hb < 10 g/dl
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C1527390 (UMLS CUI [3])
C0007766 (UMLS CUI [4])
C0007772 (UMLS CUI [5])
C0030920 (UMLS CUI [6])
C0017181 (UMLS CUI [7])
C0184661 (UMLS CUI [8,1])
C0205164 (UMLS CUI [8,2])
C1301732 (UMLS CUI [8,3])
C0032181 (UMLS CUI [9])
C0518015 (UMLS CUI [10])
Operative Surgical Procedures Planned | ADP Receptor Inhibitors Discontinuation Possible
Item
5. planned surgery which may cause discontinuation of adp-receptor antagonist
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1373149 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
Illness Serious | Malignant Neoplasms | Reduced life expectancy
Item
6. other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C1858274 (UMLS CUI [3])
Myocardial Infarction Repeated | Hospitalization Acute myocardial infarction
Item
7. repeated mi within 7 days of hospitalization for acute mi
boolean
C0027051 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0155626 (UMLS CUI [2,2])
Exclusion Criteria Angiography
Item
angiographic exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Bifurcation lesion | Culprit lesion Identification Unable
Item
bifurcated lesion unable to identify the culprit lesion
boolean
C1299363 (UMLS CUI [1])
C1299364 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Culprit lesion Location Left coronary artery main stem
Item
the culprit lesion is located in the left main artery
boolean
C1299364 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0226031 (UMLS CUI [1,3])
Diffuse Lesion | Culprit lesion Determination Unable
Item
diffusive lesions without distinguishable culprit lesion
boolean
C1707743 (UMLS CUI [1])
C1299364 (UMLS CUI [2,1])
C1148554 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Placement of stent Culprit lesion segment | STEMI caused by Stent thrombosis
Item
previous stent implantation in the culprit lesion segment or stemi caused by stent thrombosis
boolean
C0522776 (UMLS CUI [1,1])
C1299364 (UMLS CUI [1,2])
C0441635 (UMLS CUI [1,3])
C1536220 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C3897493 (UMLS CUI [2,3])
Coronary Artery Bypass Surgery Probably
Item
likely cabg procedure within 30 days
boolean
C0010055 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
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