ID

20298

Descrição

Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast–Enhanced CT Angiography of Arteries of the Heart; ODM derived from: https://clinicaltrials.gov/show/NCT00335335

Link

https://clinicaltrials.gov/show/NCT00335335

Palavras-chave

Versões (1)
  1. 20/02/2017 20/02/2017 -
Transferido a

20 de fevereiro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00335335

Inglês

Eligibility Coronary Artery Disease NCT00335335

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is ≥18 years old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
subject must have been referred for an elective coronary angiography for one of several specified conditions.
Descrição

Referral for Coronary angiography elective | Condition Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C0085532
UMLS CUI [1,3]
C0439608
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1265611
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has impaired renal function with a serum creatinine level ≥1.7 mg/dl (150
Descrição

Renal Insufficiency | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
µmol/l). if the institution’s practising guideline(s) regarding the serum creatinine limits for receiving radiologic contrast medium are lower than 1.7 mg/dl (150
Descrição

Serum creatinine level Limit RADIOLOGICAL/CONTRAST MEDIA

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600061
UMLS CUI [1,2]
C2349209
UMLS CUI [1,3]
C1875717
µmol/l), the investigator should follow the practising guideline(s) of their institution.
Descrição

Clinical Practice Guideline Comply

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0282451
UMLS CUI [1,2]
C0725694
subject has a known allergy to iodinated contrast agent
Descrição

Hypersensitivity iodinated contrast dye

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0879373
subject has atrial fibrillation/flutter or any irregular heart rhythm considered to interfere with temporal acquisition of cardiac ct images.
Descrição

Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia Interferes with Computerized Tomography (CT Scan) of Heart

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0004239
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2454744
the subject’s resting heart rate is 66-100 bpm and β-blocker therapy is contraindicated.
Descrição

RESTING HEART RATE | Medical contraindication Adrenergic beta-Antagonists

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1821417
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0001645
use of nitroglycerin is contraindicated.
Descrição

Medical contraindication Nitroglycerin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0017887
subject has had a prior cabg procedure.
Descrição

Coronary Artery Bypass Surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0010055
subject has a metal cardiac stent in place or artificial heart valve(s).
Descrição

Metal stent cardiac | artificial heart valve

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0441290
UMLS CUI [1,2]
C0018787
UMLS CUI [2]
C1399223
subject has had a prior pacemaker or internal defibrillator lead implantation. subject must agree to discontinue metformin day of and for 48 hours after the cta procedure.
Descrição

Implantation of cardiac pacemaker | Implantation of internal cardiac defibrillator | Metformin To be stopped | CT angiography

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0189842
UMLS CUI [2]
C1273352
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C1272691
UMLS CUI [4]
C1536105
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Similar models

Eligibility Coronary Artery Disease NCT00335335

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is ≥18 years old.
boolean
C0001779 (UMLS CUI [1])
Referral for Coronary angiography elective | Condition Quantity
Item
subject must have been referred for an elective coronary angiography for one of several specified conditions.
boolean
C2585524 (UMLS CUI [1,1])
C0085532 (UMLS CUI [1,2])
C0439608 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency | Creatinine measurement, serum
Item
the subject has impaired renal function with a serum creatinine level ≥1.7 mg/dl (150
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Serum creatinine level Limit RADIOLOGICAL/CONTRAST MEDIA
Item
µmol/l). if the institution’s practising guideline(s) regarding the serum creatinine limits for receiving radiologic contrast medium are lower than 1.7 mg/dl (150
boolean
C0600061 (UMLS CUI [1,1])
C2349209 (UMLS CUI [1,2])
C1875717 (UMLS CUI [1,3])
Clinical Practice Guideline Comply
Item
µmol/l), the investigator should follow the practising guideline(s) of their institution.
boolean
C0282451 (UMLS CUI [1,1])
C0725694 (UMLS CUI [1,2])
Hypersensitivity iodinated contrast dye
Item
subject has a known allergy to iodinated contrast agent
boolean
C0020517 (UMLS CUI [1,1])
C0879373 (UMLS CUI [1,2])
Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia Interferes with Computerized Tomography (CT Scan) of Heart
Item
subject has atrial fibrillation/flutter or any irregular heart rhythm considered to interfere with temporal acquisition of cardiac ct images.
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2454744 (UMLS CUI [3,3])
RESTING HEART RATE | Medical contraindication Adrenergic beta-Antagonists
Item
the subject’s resting heart rate is 66-100 bpm and β-blocker therapy is contraindicated.
boolean
C1821417 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0001645 (UMLS CUI [2,2])
Medical contraindication Nitroglycerin
Item
use of nitroglycerin is contraindicated.
boolean
C1301624 (UMLS CUI [1,1])
C0017887 (UMLS CUI [1,2])
Coronary Artery Bypass Surgery
Item
subject has had a prior cabg procedure.
boolean
C0010055 (UMLS CUI [1])
Metal stent cardiac | artificial heart valve
Item
subject has a metal cardiac stent in place or artificial heart valve(s).
boolean
C0441290 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C1399223 (UMLS CUI [2])
Implantation of cardiac pacemaker | Implantation of internal cardiac defibrillator | Metformin To be stopped | CT angiography
Item
subject has had a prior pacemaker or internal defibrillator lead implantation. subject must agree to discontinue metformin day of and for 48 hours after the cta procedure.
boolean
C0189842 (UMLS CUI [1])
C1273352 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C1536105 (UMLS CUI [4])
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