ID

31001

Descripción

Safety and Efficacy Study of CYPHER® Sirolimus Stent and ENDEAVOR® Zotarolimus Stent in Patients With Acute ST Elevation Myocardial Infarction (STEMI) and Analysis of Current Status of Emergency PCI Green Channel for STEMI Patients in China; ODM derived from: https://clinicaltrials.gov/show/NCT00781716

Link

https://clinicaltrials.gov/show/NCT00781716

Palabras clave

Versiones (1)
  1. 09.07.18 09.07.18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

9. Juli 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Myocardial Infarction NCT00781716

Inglés

Eligibility Myocardial Infarction NCT00781716

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the patient must be ≥18 years and ≤75 of age.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. prolonged, continuous (≥ 30 min) chest pain despite nitrate and: (1) st-segment elevation ≥ at least 2 leads, with reciprocal st-segment elevation ≥ 0.05mv and precordial leads st-segment elevation ≥ 0.01mv, or (2) newly developed left bundle branch block
Descripción

Chest Pain Prolonged Duration | Nitrate | ST segment elevation | ST segment elevation over precordial leads on ECG | Left Bundle-Branch Block New

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008031
UMLS CUI [1,2]
C0439590
UMLS CUI [1,3]
C0449238
UMLS CUI [2]
C0699857
UMLS CUI [3]
C0520886
UMLS CUI [4]
C4228865
UMLS CUI [5,1]
C0023211
UMLS CUI [5,2]
C0205314
3. symptoms ≥ 30 min and ≤12 hours
Descripción

Symptoms Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0449238
4. the patient has consented to participate and has authorized the collection and release of his medical information by signing the "patient informed consent form"
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
5. all lesions requiring interventions in one or more native coronary arteries are amendable for implantation of one or more cypher® sirolimus-eluting coronary stent system or endeavor® zotarolimus-eluting coronary stent
Descripción

Lesion Coronary artery Native Quantity | Requirement Intervention | Other Coding | Implantation Sirolimus drug-eluting stent | Other Coding | Implantation Zotarolimus Drug-Eluting Coronary Stents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205042
UMLS CUI [1,3]
C0302891
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0184661
UMLS CUI [3]
C3846158
UMLS CUI [4,1]
C0021107
UMLS CUI [4,2]
C2199093
UMLS CUI [5]
C3846158
UMLS CUI [6,1]
C0021107
UMLS CUI [6,2]
C1700035
UMLS CUI [6,3]
C1262327
6. the patient or guardian is willing and able to cooperate with study procedures and required follow up visits.
Descripción

Protocol Compliance | Protocol Compliance Guardian

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1274041
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant and breast-feeding female and female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032992
2. systemic (intravenous) sirolimus use within 12 months.
Descripción

Sirolimus Intravenous Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0072980
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0205373
3. patients with hypersensitivity or allergies to one of the drugs or components indicated in the instructions for use of either stents.
Descripción

Pharmaceutical Preparations Use of Stent | Hypersensitivity Pharmaceutical Preparations Specified | Hypersensitivity Component Pharmaceutical Preparations Specified

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0038257
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0205369
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1705248
UMLS CUI [3,3]
C0013227
UMLS CUI [3,4]
C0205369
4. history of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
Descripción

Bleeding tendency | Blood Coagulation Disorders | Heparin-induced thrombocytopenia | Transfusion blood refusal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3]
C0272285
UMLS CUI [4]
C0749628
5. gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
Descripción

Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage | Major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2]
C0919591
UMLS CUI [3]
C0679637
6. current platelet count <100 x 10^9cells/l or hgb <10 g/dl.
Descripción

Platelet Count measurement | Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0518015
7. fibrinolytic therapy for current mi treatment
Descripción

Thrombolytic Therapy Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040044
UMLS CUI [1,2]
C0027051
8. previous coronary intervention on target vessel or post-cabg vessel disease
Descripción

Intervention Coronary Target vessel | Vascular Disease Post Coronary Artery Bypass Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1522318
UMLS CUI [1,3]
C0449618
UMLS CUI [2,1]
C0042373
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0010055
9. transplant patients
Descripción

Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040732
10. patients with ef<25%
Descripción

Cardiac ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232174
11. patients with cardiogenic shock; with a life expectancy shorter than 12 months
Descripción

Shock, Cardiogenic | Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2]
C0023671
12. severe kidney dysfunction: creatinine level ≥2.0mg/dl or dependence on dialysis.
Descripción

Renal dysfunction Severe | Creatinine measurement, serum | Dependence on renal dialysis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0524376
13. severe hepatic dysfunction (ast and alt ≥ 3 times upper normal reference values).
Descripción

Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
14. the patient is currently, and during the crest-mi study, participating in another investigational device or drug study that clinically interferes with the crest-mi study endpoints; or requires coronary angiography or other coronary artery imaging procedures. the patient may only be enrolled in the crest-mi study once.
Descripción

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Interference Endpoints Current | Patient need for Coronary angiography | Patient need for Coronary artery Imaging Procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C0521102
UMLS CUI [4,2]
C2349179
UMLS CUI [4,3]
C0521116
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C0085532
UMLS CUI [6,1]
C0686904
UMLS CUI [6,2]
C0205042
UMLS CUI [6,3]
C0079595
15. severe tortuous or calcified vessel; stent can not or has difficulty to go through; blood vessel diameter is smaller than the minimum stent diameter available; patients unsuitable for stent implantation.
Descripción

Blood Vessel Tortuous Severe | Blood Vessel Calcified Severe | Stent Problem | Blood Vessel Diameter Inappropriate Stent | Patient Inappropriate Placement of stent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005847
UMLS CUI [1,2]
C4068863
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0005847
UMLS CUI [2,2]
C0175895
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0038257
UMLS CUI [3,2]
C0033213
UMLS CUI [4,1]
C0005847
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C1548788
UMLS CUI [4,4]
C0038257
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C0522776
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Similar models

Eligibility Myocardial Infarction NCT00781716

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. the patient must be ≥18 years and ≤75 of age.
boolean
C0001779 (UMLS CUI [1])
Chest Pain Prolonged Duration | Nitrate | ST segment elevation | ST segment elevation over precordial leads on ECG | Left Bundle-Branch Block New
Item
2. prolonged, continuous (≥ 30 min) chest pain despite nitrate and: (1) st-segment elevation ≥ at least 2 leads, with reciprocal st-segment elevation ≥ 0.05mv and precordial leads st-segment elevation ≥ 0.01mv, or (2) newly developed left bundle branch block
boolean
C0008031 (UMLS CUI [1,1])
C0439590 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0699857 (UMLS CUI [2])
C0520886 (UMLS CUI [3])
C4228865 (UMLS CUI [4])
C0023211 (UMLS CUI [5,1])
C0205314 (UMLS CUI [5,2])
Symptoms Duration
Item
3. symptoms ≥ 30 min and ≤12 hours
boolean
C1457887 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Informed Consent
Item
4. the patient has consented to participate and has authorized the collection and release of his medical information by signing the "patient informed consent form"
boolean
C0021430 (UMLS CUI [1])
Lesion Coronary artery Native Quantity | Requirement Intervention | Other Coding | Implantation Sirolimus drug-eluting stent | Other Coding | Implantation Zotarolimus Drug-Eluting Coronary Stents
Item
5. all lesions requiring interventions in one or more native coronary arteries are amendable for implantation of one or more cypher® sirolimus-eluting coronary stent system or endeavor® zotarolimus-eluting coronary stent
boolean
C0221198 (UMLS CUI [1,1])
C0205042 (UMLS CUI [1,2])
C0302891 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C1514873 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
C0021107 (UMLS CUI [4,1])
C2199093 (UMLS CUI [4,2])
C3846158 (UMLS CUI [5])
C0021107 (UMLS CUI [6,1])
C1700035 (UMLS CUI [6,2])
C1262327 (UMLS CUI [6,3])
Protocol Compliance | Protocol Compliance Guardian
Item
6. the patient or guardian is willing and able to cooperate with study procedures and required follow up visits.
boolean
C0525058 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy
Item
1. pregnant and breast-feeding female and female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
Sirolimus Intravenous Systemic
Item
2. systemic (intravenous) sirolimus use within 12 months.
boolean
C0072980 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
Pharmaceutical Preparations Use of Stent | Hypersensitivity Pharmaceutical Preparations Specified | Hypersensitivity Component Pharmaceutical Preparations Specified
Item
3. patients with hypersensitivity or allergies to one of the drugs or components indicated in the instructions for use of either stents.
boolean
C0013227 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1705248 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0205369 (UMLS CUI [3,4])
Bleeding tendency | Blood Coagulation Disorders | Heparin-induced thrombocytopenia | Transfusion blood refusal
Item
4. history of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0272285 (UMLS CUI [3])
C0749628 (UMLS CUI [4])
Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage | Major surgery
Item
5. gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
boolean
C0017181 (UMLS CUI [1])
C0919591 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
Platelet Count measurement | Hemoglobin measurement
Item
6. current platelet count <100 x 10^9cells/l or hgb <10 g/dl.
boolean
C0032181 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Thrombolytic Therapy Myocardial Infarction
Item
7. fibrinolytic therapy for current mi treatment
boolean
C0040044 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Intervention Coronary Target vessel | Vascular Disease Post Coronary Artery Bypass Surgery
Item
8. previous coronary intervention on target vessel or post-cabg vessel disease
boolean
C0184661 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
C0042373 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0010055 (UMLS CUI [2,3])
Transplantation
Item
9. transplant patients
boolean
C0040732 (UMLS CUI [1])
Cardiac ejection fraction
Item
10. patients with ef<25%
boolean
C0232174 (UMLS CUI [1])
Shock, Cardiogenic | Life Expectancy
Item
11. patients with cardiogenic shock; with a life expectancy shorter than 12 months
boolean
C0036980 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Renal dysfunction Severe | Creatinine measurement, serum | Dependence on renal dialysis
Item
12. severe kidney dysfunction: creatinine level ≥2.0mg/dl or dependence on dialysis.
boolean
C3279454 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C0524376 (UMLS CUI [3])
Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
13. severe hepatic dysfunction (ast and alt ≥ 3 times upper normal reference values).
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Interference Endpoints Current | Patient need for Coronary angiography | Patient need for Coronary artery Imaging Procedure
Item
14. the patient is currently, and during the crest-mi study, participating in another investigational device or drug study that clinically interferes with the crest-mi study endpoints; or requires coronary angiography or other coronary artery imaging procedures. the patient may only be enrolled in the crest-mi study once.
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0521102 (UMLS CUI [4,1])
C2349179 (UMLS CUI [4,2])
C0521116 (UMLS CUI [4,3])
C0686904 (UMLS CUI [5,1])
C0085532 (UMLS CUI [5,2])
C0686904 (UMLS CUI [6,1])
C0205042 (UMLS CUI [6,2])
C0079595 (UMLS CUI [6,3])
Blood Vessel Tortuous Severe | Blood Vessel Calcified Severe | Stent Problem | Blood Vessel Diameter Inappropriate Stent | Patient Inappropriate Placement of stent
Item
15. severe tortuous or calcified vessel; stent can not or has difficulty to go through; blood vessel diameter is smaller than the minimum stent diameter available; patients unsuitable for stent implantation.
boolean
C0005847 (UMLS CUI [1,1])
C4068863 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0005847 (UMLS CUI [2,1])
C0175895 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0038257 (UMLS CUI [3,1])
C0033213 (UMLS CUI [3,2])
C0005847 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0038257 (UMLS CUI [4,4])
C0030705 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C0522776 (UMLS CUI [5,3])
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