ID

35551

Beschrijving

Impact of Breathing Maneuvers on the Oxygenation Supply of the Heart Assessed With MRI in Patients With Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02233634

Link

https://clinicaltrials.gov/show/NCT02233634

Trefwoorden

Versies (1)
  1. 08-03-19 08-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02233634

Engels

Eligibility Coronary Artery Disease NCT02233634

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with known relevant coronary artery stenosis (defined by previous coronary angiography, qca: reduction in lumen-diameter of the vessel >50%) with a scheduled intervention to treat this stenosis (staged pci)
Beschrijving

Coronary Stenosis Quantitative Coronary Angiography | Vessel lumen diameter reduction Percentage | Staged Percutaneous Coronary Intervention Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C4054139
UMLS CUI [2,1]
C1443265
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C3272260
UMLS CUI [3,2]
C0205539
cmr feasible prior to intervention
Beschrijving

Magnetic resonance Cardiovascular | Status pre- Intervention

Datatype

boolean

Alias
UMLS CUI [1,1]
C1551403
UMLS CUI [1,2]
C3887460
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0184661
age ≥18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
for healthy participants: absence of cardiovascular and lung disease, and absence of medication with cardiovascular effects
Beschrijving

Healthy Volunteers | Cardiovascular Disease Absent | Lung disease Absent | Cardiovascular Agents Absent

Datatype

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0007220
UMLS CUI [4,2]
C0332197
absence of exclusion criteria
Beschrijving

Exclusion Criteria Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
general contraindication against mri-scans: (claustrophobia, ferromagnetic implants, clips, pacemakers, shrapnels, ophthalmic metal deposits)
Beschrijving

Medical contraindication MRI scan | Claustrophobia | Implants Magnetic | Clips | Artificial cardiac pacemaker | Shrapnel | Eye deposit Metallic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0008909
UMLS CUI [3,1]
C0021102
UMLS CUI [3,2]
C0563532
UMLS CUI [4]
C0175722
UMLS CUI [5]
C0030163
UMLS CUI [6]
C0522670
UMLS CUI [7,1]
C0541865
UMLS CUI [7,2]
C2986473
pregnancy or inconclusive test result
Beschrijving

Pregnancy | Pregnancy test result Inconclusive

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0427777
UMLS CUI [2,2]
C0205258
age <18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
inability to give informed consent
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
consumption of caffeine, tea, treatment of dipyridamol <12h before the scan
Beschrijving

Caffeine consumption | Tea consumption | Dipyridamole

Datatype

boolean

Alias
UMLS CUI [1]
C0948365
UMLS CUI [2,1]
C0039400
UMLS CUI [2,2]
C0009830
UMLS CUI [3]
C0012582
medication with calcium antagonists (ok, if can be paused on the day of the scan)
Beschrijving

Calcium antagonists

Datatype

boolean

Alias
UMLS CUI [1]
C0006684
constant medication with nitrates (ok, if can be paused on the day of the scan)
Beschrijving

Nitrates

Datatype

boolean

Alias
UMLS CUI [1]
C0028125
medication with methyl-xanthines
Beschrijving

methylxanthine

Datatype

boolean

Alias
UMLS CUI [1]
C0066447
acute myocardial ischemia/myocardial infarction
Beschrijving

Acute myocardial ischemia | Acute myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0746731
UMLS CUI [2]
C0155626
coronary bypass
Beschrijving

Coronary Artery Bypass Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0010055
pulmonary disease
Beschrijving

Lung disease

Datatype

boolean

Alias
UMLS CUI [1]
C0024115
enrolment of the investigator, his/her family members, employees and other dependent persons
Beschrijving

Enrollment Investigator | Enrollment Family member | Enrollment Employee | Enrollment Persons dependent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C0086282
UMLS CUI [3,1]
C1516879
UMLS CUI [3,2]
C0599987
UMLS CUI [4,1]
C1516879
UMLS CUI [4,2]
C0027361
UMLS CUI [4,3]
C3244310
presence of cardiac or lung disease for healthy volunteers, nicotine consumption within the last 6 months
Beschrijving

Heart Disease | Lung disease | Nicotine Consumption

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0024115
UMLS CUI [3,1]
C0028040
UMLS CUI [3,2]
C0009830
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Similar models

Eligibility Coronary Artery Disease NCT02233634

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Coronary Stenosis Quantitative Coronary Angiography | Vessel lumen diameter reduction Percentage | Staged Percutaneous Coronary Intervention Scheduled
Item
patients with known relevant coronary artery stenosis (defined by previous coronary angiography, qca: reduction in lumen-diameter of the vessel >50%) with a scheduled intervention to treat this stenosis (staged pci)
boolean
C0242231 (UMLS CUI [1,1])
C4054139 (UMLS CUI [1,2])
C1443265 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C3272260 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
Magnetic resonance Cardiovascular | Status pre- Intervention
Item
cmr feasible prior to intervention
boolean
C1551403 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
Age
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Healthy Volunteers | Cardiovascular Disease Absent | Lung disease Absent | Cardiovascular Agents Absent
Item
for healthy participants: absence of cardiovascular and lung disease, and absence of medication with cardiovascular effects
boolean
C1708335 (UMLS CUI [1])
C0007222 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0007220 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Exclusion Criteria Absent
Item
absence of exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication MRI scan | Claustrophobia | Implants Magnetic | Clips | Artificial cardiac pacemaker | Shrapnel | Eye deposit Metallic
Item
general contraindication against mri-scans: (claustrophobia, ferromagnetic implants, clips, pacemakers, shrapnels, ophthalmic metal deposits)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C0021102 (UMLS CUI [3,1])
C0563532 (UMLS CUI [3,2])
C0175722 (UMLS CUI [4])
C0030163 (UMLS CUI [5])
C0522670 (UMLS CUI [6])
C0541865 (UMLS CUI [7,1])
C2986473 (UMLS CUI [7,2])
Pregnancy | Pregnancy test result Inconclusive
Item
pregnancy or inconclusive test result
boolean
C0032961 (UMLS CUI [1])
C0427777 (UMLS CUI [2,1])
C0205258 (UMLS CUI [2,2])
Age
Item
age <18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable
Item
inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Caffeine consumption | Tea consumption | Dipyridamole
Item
consumption of caffeine, tea, treatment of dipyridamol <12h before the scan
boolean
C0948365 (UMLS CUI [1])
C0039400 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0012582 (UMLS CUI [3])
Calcium antagonists
Item
medication with calcium antagonists (ok, if can be paused on the day of the scan)
boolean
C0006684 (UMLS CUI [1])
Nitrates
Item
constant medication with nitrates (ok, if can be paused on the day of the scan)
boolean
C0028125 (UMLS CUI [1])
methylxanthine
Item
medication with methyl-xanthines
boolean
C0066447 (UMLS CUI [1])
Acute myocardial ischemia | Acute myocardial infarction
Item
acute myocardial ischemia/myocardial infarction
boolean
C0746731 (UMLS CUI [1])
C0155626 (UMLS CUI [2])
Coronary Artery Bypass Surgery
Item
coronary bypass
boolean
C0010055 (UMLS CUI [1])
Lung disease
Item
pulmonary disease
boolean
C0024115 (UMLS CUI [1])
Enrollment Investigator | Enrollment Family member | Enrollment Employee | Enrollment Persons dependent
Item
enrolment of the investigator, his/her family members, employees and other dependent persons
boolean
C1516879 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C1516879 (UMLS CUI [2,1])
C0086282 (UMLS CUI [2,2])
C1516879 (UMLS CUI [3,1])
C0599987 (UMLS CUI [3,2])
C1516879 (UMLS CUI [4,1])
C0027361 (UMLS CUI [4,2])
C3244310 (UMLS CUI [4,3])
Heart Disease | Lung disease | Nicotine Consumption
Item
presence of cardiac or lung disease for healthy volunteers, nicotine consumption within the last 6 months
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0028040 (UMLS CUI [3,1])
C0009830 (UMLS CUI [3,2])
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