Informações:
Falhas:
ID
34840
Descrição
SMART China, A Multi-center Clinical Registry Study; ODM derived from: https://clinicaltrials.gov/show/NCT02485925
Link
https://clinicaltrials.gov/show/NCT02485925
Palavras-chave
Versões (1)
- 31/01/2019 31/01/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
31 de janeiro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02485925
Eligibility Atrial Fibrillation NCT02485925
- StudyEvent: Eligibility
Similar models
Eligibility Atrial Fibrillation NCT02485925
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
1. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Anti-Arrhythmia Agents Atrial Fibrillation | Anti-Arrhythmia Agents Quantity failed | Anti-Arrhythmia Agents Class | Adrenergic beta-1 Receptor Antagonists | Calcium Channel Blockers | Recurrent symptomatic atrial fibrillation | Intolerance to Anti-Arrhythmia Agents
Item
2. failure of at least one antiarrhythmic drug (aad) for af (class i or iii, or av nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic af, or intolerance to the aad
boolean
C0003195 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0003195 (UMLS CUI [3,1])
C0456387 (UMLS CUI [3,2])
C0304516 (UMLS CUI [4])
C0006684 (UMLS CUI [5])
C1739416 (UMLS CUI [6])
C1744706 (UMLS CUI [7,1])
C0003195 (UMLS CUI [7,2])
C0004238 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0003195 (UMLS CUI [3,1])
C0456387 (UMLS CUI [3,2])
C0304516 (UMLS CUI [4])
C0006684 (UMLS CUI [5])
C1739416 (UMLS CUI [6])
C1744706 (UMLS CUI [7,1])
C0003195 (UMLS CUI [7,2])
Paroxysmal atrial fibrillation Eligible Catheter ablation
Item
3. patients with paroxysmal af eligible for catheter ablation
boolean
C0235480 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0162563 (UMLS CUI [1,3])
C1548635 (UMLS CUI [1,2])
C0162563 (UMLS CUI [1,3])
Paroxysmal atrial fibrillation Symptomatic | Paroxysmal atrial fibrillation Episode Quantity | Electrocardiography | Holter Electrocardiography | Other Coding
Item
4. patients with symptomatic paf who have had at least one documented af episode in the six (6) months prior to enrollment. documentation may include but is not limited to electrocardiogram (ecg), holter monitor (hm) or transtelephonic monitor (ttm)
boolean
C0235480 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0235480 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1623258 (UMLS CUI [3])
C0013801 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C0231220 (UMLS CUI [1,2])
C0235480 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1623258 (UMLS CUI [3])
C0013801 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
Protocol Compliance
Item
5. able and willing to comply with all pre-, post- and follow-up testing and requirements
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
6. be able to sign irb/ec-approved informed consent form
boolean
C0021430 (UMLS CUI [1])
Atrial Fibrillation Secondary to Electrolyte imbalance | Atrial Fibrillation Secondary to Thyroid Disease | Atrial Fibrillation Reversible | Atrial Fibrillation Absence Cause cardiac
Item
1. af secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0342579 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0040128 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C0205343 (UMLS CUI [3,2])
C0004238 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0015127 (UMLS CUI [4,3])
C0018787 (UMLS CUI [4,4])
C0175668 (UMLS CUI [1,2])
C0342579 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0040128 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C0205343 (UMLS CUI [3,2])
C0004238 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0015127 (UMLS CUI [4,3])
C0018787 (UMLS CUI [4,4])
Destructive procedure (surgical) Atrial Fibrillation | Catheter ablation for atrial fibrillation
Item
2. previous surgical or catheter ablation for af
boolean
C1261381 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C2702800 (UMLS CUI [2])
C0004238 (UMLS CUI [1,2])
C2702800 (UMLS CUI [2])
Percutaneous Coronary Intervention | Cardiac Surgery procedures | Heart Valve Operative Surgical Procedures | Heart Valve Procedure Percutaneous | Ventriculotomy | Incision of atrium of heart | Repair of heart valve | Heart valve replacement | Heart Valve Prosthesis
Item
3. any pci, cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a prosthetic valve) within the past 2 months.
boolean
C1532338 (UMLS CUI [1])
C0018821 (UMLS CUI [2])
C0018826 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0018826 (UMLS CUI [4,1])
C0184661 (UMLS CUI [4,2])
C0522523 (UMLS CUI [4,3])
C0750201 (UMLS CUI [5])
C0189760 (UMLS CUI [6])
C0190112 (UMLS CUI [7])
C0190173 (UMLS CUI [8])
C0018825 (UMLS CUI [9])
C0018821 (UMLS CUI [2])
C0018826 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0018826 (UMLS CUI [4,1])
C0184661 (UMLS CUI [4,2])
C0522523 (UMLS CUI [4,3])
C0750201 (UMLS CUI [5])
C0189760 (UMLS CUI [6])
C0190112 (UMLS CUI [7])
C0190173 (UMLS CUI [8])
C0018825 (UMLS CUI [9])
Carotid Artery Stenting | Carotid Endarterectomy
Item
4. any carotid stenting or endarterectomy.
boolean
C0007272 (UMLS CUI [1,1])
C2348535 (UMLS CUI [1,2])
C0014099 (UMLS CUI [2])
C2348535 (UMLS CUI [1,2])
C0014099 (UMLS CUI [2])
Coronary Artery Bypass Surgery
Item
5. coronary artery bypass graft (cabg) procedure within the last 180 days (6 months)
boolean
C0010055 (UMLS CUI [1])
Episode of Atrial Fibrillation Duration | Cardioversion Episode of Atrial Fibrillation
Item
6. af episodes lasting longer than 7 days or terminated via cardioversion
boolean
C0332189 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0013778 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
C0004238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0013778 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
Thrombus of left atrium Imaging
Item
7. documented left atrial thrombus on imaging
boolean
C3532827 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,2])
Heart failure Uncontrolled | Heart failure New York Heart Association Classification
Item
8. uncontrolled heart failure or new york heart association (nyha) class iii or iv
boolean
C0018801 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0205318 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Myocardial Infarction
Item
9. myocardial infarction within the previous 60 days (2 months)
boolean
C0027051 (UMLS CUI [1])
Thromboembolism | Transient Ischemic Attack
Item
10. documented thromboembolic event (including tia) within the past 12 months
boolean
C0040038 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0007787 (UMLS CUI [2])
Rheumatic Heart Disease
Item
11. rheumatic heart disease
boolean
C0035439 (UMLS CUI [1])
Heart Transplantation Anticipated | Cardiac Surgery procedure Anticipated
Item
12. awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
boolean
C0018823 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0018821 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
C3840775 (UMLS CUI [1,2])
C0018821 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Lung diseases | Restrictive pulmonary disease | Airway constriction | Chronic Obstructive Airway Disease | Lung malfunction | Respiration Disorders | Respiratory Failure
Item
13. significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
boolean
C0024115 (UMLS CUI [1])
C0877013 (UMLS CUI [2])
C0231818 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0024109 (UMLS CUI [5,1])
C0231174 (UMLS CUI [5,2])
C0035204 (UMLS CUI [6])
C1145670 (UMLS CUI [7])
C0877013 (UMLS CUI [2])
C0231818 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0024109 (UMLS CUI [5,1])
C0231174 (UMLS CUI [5,2])
C0035204 (UMLS CUI [6])
C1145670 (UMLS CUI [7])
Congenital Abnormality Study Subject Participation Status Excluded | Medical Problem Study Subject Participation Status Excluded
Item
14. significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
boolean
C0000768 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1254481 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1254481 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Illness | Sepsis
Item
15. active illness or active systemic infection or sepsis
boolean
C0221423 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
C0243026 (UMLS CUI [2])
Atrial myxoma
Item
16. diagnosed atrial myxoma
boolean
C0151241 (UMLS CUI [1])
Angina, Unstable
Item
17. unstable angina within the past 60 days (2 months)
boolean
C0002965 (UMLS CUI [1])
Blood coagulation | Bleeding tendency
Item
18. history of blood clotting or bleeding abnormalities
boolean
C0005778 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C1458140 (UMLS CUI [2])
Life Expectancy
Item
19. life expectancy less than 365 days (12 months)
boolean
C0023671 (UMLS CUI [1])
Hypertrophic Cardiomyopathy
Item
20. hypertrophic obstructive cardiomyopathy
boolean
C0007194 (UMLS CUI [1])
Implantable defibrillator
Item
21. presence of implanted icd
boolean
C0162589 (UMLS CUI [1])
Medical contraindication Anticoagulation Therapy
Item
22. contraindication to anticoagulation
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,2])
Medical contraindication Isoproterenol
Item
23. contraindication to isoproterenol
boolean
C1301624 (UMLS CUI [1,1])
C0022245 (UMLS CUI [1,2])
C0022245 (UMLS CUI [1,2])
Thrombus intramural Excludes Catheterization | Malignant Neoplasm Excludes Catheterization | Abnormality Excludes Catheterization | Thrombus intramural Excludes Manipulation of catheter | Malignant Neoplasm Excludes Manipulation of catheter | Abnormality Excludes Manipulation of catheter
Item
24. presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation
boolean
C0087086 (UMLS CUI [1,1])
C0205102 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0007430 (UMLS CUI [1,4])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0007430 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0007430 (UMLS CUI [3,3])
C0087086 (UMLS CUI [4,1])
C0205102 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0522773 (UMLS CUI [4,4])
C0006826 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0522773 (UMLS CUI [5,3])
C1704258 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0522773 (UMLS CUI [6,3])
C0205102 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0007430 (UMLS CUI [1,4])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0007430 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0007430 (UMLS CUI [3,3])
C0087086 (UMLS CUI [4,1])
C0205102 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0522773 (UMLS CUI [4,4])
C0006826 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0522773 (UMLS CUI [5,3])
C1704258 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0522773 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
25. women who are pregnant and/or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Condition Excludes Vascular access
Item
26. presence of a condition that precludes vascular access.
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0750138 (UMLS CUI [1,3])
C0332196 (UMLS CUI [1,2])
C0750138 (UMLS CUI [1,3])
Medical contraindication Clinical Trial Catheter
Item
27. patients presenting contraindications for study catheter(s), as indicated in the respective instructions for use
boolean
C1301624 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0085590 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0085590 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trial Investigational | Evaluation Investigational Medical Device | Evaluation Biological agents | Evaluation Investigational New Drugs
Item
28. enrollment in an investigational study evaluating another device, biologic, or drug.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C2346570 (UMLS CUI [3,2])
C1261322 (UMLS CUI [4,1])
C0005515 (UMLS CUI [4,2])
C1261322 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
C0008976 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C2346570 (UMLS CUI [3,2])
C1261322 (UMLS CUI [4,1])
C0005515 (UMLS CUI [4,2])
C1261322 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])