ID

40496

Description

Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson; ODM derived from: https://clinicaltrials.gov/show/NCT01779869

Link

https://clinicaltrials.gov/show/NCT01779869

Keywords

Versions (1)
  1. 4/26/20 4/26/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 26, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Ischemic Heart Disease NCT01779869

English

Eligibility Ischemic Heart Disease NCT01779869

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have had a clinically ordered rest/regadenoson single-isotope spect-mpi study within 10 days prior to cardiac pet-mri examination
Description

Regadenoson At rest | SPECT MPI | Status pre- PET/MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1698215
UMLS CUI [1,2]
C0443144
UMLS CUI [2,1]
C0040399
UMLS CUI [2,2]
C2350390
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C3641326
reversible perfusion abnormalities on spect imaging in at least 2 contiguous myocardial segments
Description

Myocardial perfusion Abnormality SPECT | Segment Myocardial Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0428857
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0040399
UMLS CUI [2,1]
C0441635
UMLS CUI [2,2]
C1522564
UMLS CUI [2,3]
C1265611
patients for whom standard of care coronary ica is planned
Description

Standard of Care Planned | Invasive Coronary Angiography Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0085532
UMLS CUI [2,2]
C0205281
UMLS CUI [2,3]
C1301732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
an clinical event (ie; worsening angina pectoris or myocardial infarction) occuring after the spect-mpi and before the cardiac mri examination
Description

Event Clinical | Worsening Angina Pectoris | Worsening Myocardial Infarction | Status post SPECT MPI | Status pre- MRI of Heart

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C0332271
UMLS CUI [2,2]
C0002962
UMLS CUI [3,1]
C0332271
UMLS CUI [3,2]
C0027051
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0040399
UMLS CUI [4,3]
C2350390
UMLS CUI [5,1]
C0332152
UMLS CUI [5,2]
C0412692
myocardial revascularization occuring after the spect-mpi and before the cardiac mri examination
Description

Myocardial Revascularization | Status post SPECT MPI | Status pre- MRI of Heart

Data type

boolean

Alias
UMLS CUI [1]
C0027056
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0040399
UMLS CUI [2,3]
C2350390
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0412692
contraindications to mr imaging (pacemaker, brain aneurysm clips, shrapnel, etc.)
Description

Medical contraindication MRI | Artificial cardiac pacemaker | Aneurysm clip | Shrapnel

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0179977
UMLS CUI [4]
C0522670
renal insufficiency (gfr < 60 ml/min/1.73m2)
Description

Renal Insufficiency | Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0017654
allergy or other contraindication to gadolinium-based mr contrast agent
Description

Hypersensitivity Gadolinium-based Contrast Agent | Medical contraindication Gadolinium-based Contrast Agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3249258
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C3249258
second or third degree atrioventricular (av) block
Description

Second degree atrioventricular block | Complete atrioventricular block

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
active asthma
Description

Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
seizures
Description

Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0036572
current hypotension (<100/60)
Description

Hypotension | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0005824
current hypertension (>160/90)
Description

Hypertensive disease | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0005824
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
breast feeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
use of caffeine, nicotine or over the counter cold medicines within 12 hours of the cardiac pet-mri examination
Description

Caffeine | Nicotine | Non-Prescription Drugs Cold

Data type

boolean

Alias
UMLS CUI [1]
C0006644
UMLS CUI [2]
C0028040
UMLS CUI [3,1]
C0013231
UMLS CUI [3,2]
C0009443
use of the medication dipyridamole within 48 hrs of the cardiac pet-mri examination
Description

Dipyridamole

Data type

boolean

Alias
UMLS CUI [1]
C0012582
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Similar models

Eligibility Ischemic Heart Disease NCT01779869

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Regadenoson At rest | SPECT MPI | Status pre- PET/MRI
Item
patients who have had a clinically ordered rest/regadenoson single-isotope spect-mpi study within 10 days prior to cardiac pet-mri examination
boolean
C1698215 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
C0040399 (UMLS CUI [2,1])
C2350390 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C3641326 (UMLS CUI [3,2])
Myocardial perfusion Abnormality SPECT | Segment Myocardial Quantity
Item
reversible perfusion abnormalities on spect imaging in at least 2 contiguous myocardial segments
boolean
C0428857 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0040399 (UMLS CUI [1,3])
C0441635 (UMLS CUI [2,1])
C1522564 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Standard of Care Planned | Invasive Coronary Angiography Planned
Item
patients for whom standard of care coronary ica is planned
boolean
C2936643 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0085532 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Event Clinical | Worsening Angina Pectoris | Worsening Myocardial Infarction | Status post SPECT MPI | Status pre- MRI of Heart
Item
an clinical event (ie; worsening angina pectoris or myocardial infarction) occuring after the spect-mpi and before the cardiac mri examination
boolean
C0441471 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0332271 (UMLS CUI [2,1])
C0002962 (UMLS CUI [2,2])
C0332271 (UMLS CUI [3,1])
C0027051 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0040399 (UMLS CUI [4,2])
C2350390 (UMLS CUI [4,3])
C0332152 (UMLS CUI [5,1])
C0412692 (UMLS CUI [5,2])
Myocardial Revascularization | Status post SPECT MPI | Status pre- MRI of Heart
Item
myocardial revascularization occuring after the spect-mpi and before the cardiac mri examination
boolean
C0027056 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0040399 (UMLS CUI [2,2])
C2350390 (UMLS CUI [2,3])
C0332152 (UMLS CUI [3,1])
C0412692 (UMLS CUI [3,2])
Medical contraindication MRI | Artificial cardiac pacemaker | Aneurysm clip | Shrapnel
Item
contraindications to mr imaging (pacemaker, brain aneurysm clips, shrapnel, etc.)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0179977 (UMLS CUI [3])
C0522670 (UMLS CUI [4])
Renal Insufficiency | Glomerular Filtration Rate
Item
renal insufficiency (gfr < 60 ml/min/1.73m2)
boolean
C1565489 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
Hypersensitivity Gadolinium-based Contrast Agent | Medical contraindication Gadolinium-based Contrast Agent
Item
allergy or other contraindication to gadolinium-based mr contrast agent
boolean
C0020517 (UMLS CUI [1,1])
C3249258 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C3249258 (UMLS CUI [2,2])
Second degree atrioventricular block | Complete atrioventricular block
Item
second or third degree atrioventricular (av) block
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Asthma
Item
active asthma
boolean
C0004096 (UMLS CUI [1])
Seizures
Item
seizures
boolean
C0036572 (UMLS CUI [1])
Hypotension | Blood pressure determination
Item
current hypotension (<100/60)
boolean
C0020649 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Hypertensive disease | Blood pressure determination
Item
current hypertension (>160/90)
boolean
C0020538 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
breast feeding
boolean
C0006147 (UMLS CUI [1])
Caffeine | Nicotine | Non-Prescription Drugs Cold
Item
use of caffeine, nicotine or over the counter cold medicines within 12 hours of the cardiac pet-mri examination
boolean
C0006644 (UMLS CUI [1])
C0028040 (UMLS CUI [2])
C0013231 (UMLS CUI [3,1])
C0009443 (UMLS CUI [3,2])
Dipyridamole
Item
use of the medication dipyridamole within 48 hrs of the cardiac pet-mri examination
boolean
C0012582 (UMLS CUI [1])
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