ID

20369

Description

Comparison of Diagnostic Rest/Stress SPECT Results for Patients With Myocardial Ischemia and Infarction Using Myoview in Both Single and Dual Isotope Acquisition Approaches; ODM derived from: https://clinicaltrials.gov/show/NCT00381316

Lien

https://clinicaltrials.gov/show/NCT00381316

Mots-clés

Versions (1)
  1. 21/02/2017 21/02/2017 -
Téléchargé le

21 février 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00381316

Anglais

Eligibility Coronary Artery Disease NCT00381316

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the subject is 18 years old or older.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. male subjects or non-lactating female subjects, who are either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or for women of childbearing potential, the results of a serum or urine human chorionic gonadotropin pregnancy test, performed at screening within 24 hours before dosing (with the result known before investigational medicinal product administration) must be negative.
Description

Gender | Breast Feeding | Male sterilization | Female Sterilization | Bilateral oophorectomy | Hysterectomy | Postmenopausal state | Amenorrhea | Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential qualitative urine human chorionic gonadotropin measurement Negative

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0024559
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0278321
UMLS CUI [6]
C0020699
UMLS CUI [7]
C0232970
UMLS CUI [8]
C0002453
UMLS CUI [9,1]
C3831118
UMLS CUI [9,2]
C0430060
UMLS CUI [9,3]
C1513916
UMLS CUI [10,1]
C3831118
UMLS CUI [10,2]
C2188702
UMLS CUI [10,3]
C1513916
3. the subject is able and willing to comply with study procedures (i.e., 1 spect imaging at stress, 2 spect imagings at rest) and signed and dated informed consent is obtained.
Description

Protocol Compliance | SPECT Stress Quantity | SPECT At rest Quantity | Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0040399
UMLS CUI [2,2]
C0038435
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0040399
UMLS CUI [3,2]
C0443144
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C0021430
4. the subject is suspected of or known of having cad based on the subject's clinical signs, symptoms, or examinations .
Description

Coronary Artery Disease Sign or Symptom | Coronary Artery Disease Symptoms | Coronary Artery Disease Examination

Type de données

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C3540840
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C1457887
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0031809
5. the subject is referred for rest/stress (exercise or pharmacological) mps-spect for known or suspected cad (as clinically required).
Description

Combined stress and rest myocardial perfusion study Coronary Artery Disease | SPECT Coronary Artery Disease | Combined stress and rest myocardial perfusion study Exercise | SPECT pharmacological | Combined stress and rest myocardial perfusion study pharmacological | SPECT Exercise

Type de données

boolean

Alias
UMLS CUI [1,1]
C0846078
UMLS CUI [1,2]
C1956346
UMLS CUI [2,1]
C0040399
UMLS CUI [2,2]
C1956346
UMLS CUI [3,1]
C0846078
UMLS CUI [3,2]
C0015259
UMLS CUI [4,1]
C0040399
UMLS CUI [4,2]
C0205464
UMLS CUI [5,1]
C0846078
UMLS CUI [5,2]
C0205464
UMLS CUI [6,1]
C0040399
UMLS CUI [6,2]
C0015259
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the subject was previously included in this study.
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
2. the subject received an imp within 30 days before or is scheduled to receive one during or in the next 30 days after imp administration.
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
3. the subject has known allergies to any product used in this study or its constituents, including subjects who are not able to exercise and have contraindications to adenosine (e.g., asthmatics).
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Constituents | Exercise Unable | Medical contraindication Adenosine | Asthmatics

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0729650
UMLS CUI [3,1]
C0015259
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0001443
UMLS CUI [5]
C3816164
4. the subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month.
Description

Disease Serious | Life threatening illness | Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C3846017
UMLS CUI [3]
C0023671
5. the subject has no contraindications to any of the study procedures (e.g. physical exercise) or the involved drugs (myoview, thallium-201, adenosine or dipyridamole) such as e.g. 2nd or 3rd degree av-block, ss syndrome, bradycardia, bronchoconstrictive or bronchospastic lung disease.
Description

Medical contraindication Study Procedures | Medical contraindication Exercise | Medical contraindication Myoview | Medical contraindication Thallium-201 | Medical contraindication Adenosine | Medical contraindication Dipyridamole | Second degree atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome | Bradycardia | Bronchoconstriction | Bronchial Spasm

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C1948041
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0015259
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0379804
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0303322
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0001443
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0012582
UMLS CUI [7]
C0264906
UMLS CUI [8]
C0151517
UMLS CUI [9]
C0037052
UMLS CUI [10]
C0428977
UMLS CUI [11]
C0079043
UMLS CUI [12]
C0006266
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Similar models

Eligibility Coronary Artery Disease NCT00381316

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. the subject is 18 years old or older.
boolean
C0001779 (UMLS CUI [1])
Gender | Breast Feeding | Male sterilization | Female Sterilization | Bilateral oophorectomy | Hysterectomy | Postmenopausal state | Amenorrhea | Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential qualitative urine human chorionic gonadotropin measurement Negative
Item
2. male subjects or non-lactating female subjects, who are either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or for women of childbearing potential, the results of a serum or urine human chorionic gonadotropin pregnancy test, performed at screening within 24 hours before dosing (with the result known before investigational medicinal product administration) must be negative.
boolean
C0079399 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0024559 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0278321 (UMLS CUI [5])
C0020699 (UMLS CUI [6])
C0232970 (UMLS CUI [7])
C0002453 (UMLS CUI [8])
C3831118 (UMLS CUI [9,1])
C0430060 (UMLS CUI [9,2])
C1513916 (UMLS CUI [9,3])
C3831118 (UMLS CUI [10,1])
C2188702 (UMLS CUI [10,2])
C1513916 (UMLS CUI [10,3])
Protocol Compliance | SPECT Stress Quantity | SPECT At rest Quantity | Informed Consent
Item
3. the subject is able and willing to comply with study procedures (i.e., 1 spect imaging at stress, 2 spect imagings at rest) and signed and dated informed consent is obtained.
boolean
C0525058 (UMLS CUI [1])
C0040399 (UMLS CUI [2,1])
C0038435 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0040399 (UMLS CUI [3,1])
C0443144 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0021430 (UMLS CUI [4])
Coronary Artery Disease Sign or Symptom | Coronary Artery Disease Symptoms | Coronary Artery Disease Examination
Item
4. the subject is suspected of or known of having cad based on the subject's clinical signs, symptoms, or examinations .
boolean
C1956346 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C1956346 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
Combined stress and rest myocardial perfusion study Coronary Artery Disease | SPECT Coronary Artery Disease | Combined stress and rest myocardial perfusion study Exercise | SPECT pharmacological | Combined stress and rest myocardial perfusion study pharmacological | SPECT Exercise
Item
5. the subject is referred for rest/stress (exercise or pharmacological) mps-spect for known or suspected cad (as clinically required).
boolean
C0846078 (UMLS CUI [1,1])
C1956346 (UMLS CUI [1,2])
C0040399 (UMLS CUI [2,1])
C1956346 (UMLS CUI [2,2])
C0846078 (UMLS CUI [3,1])
C0015259 (UMLS CUI [3,2])
C0040399 (UMLS CUI [4,1])
C0205464 (UMLS CUI [4,2])
C0846078 (UMLS CUI [5,1])
C0205464 (UMLS CUI [5,2])
C0040399 (UMLS CUI [6,1])
C0015259 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
1. the subject was previously included in this study.
boolean
C2348568 (UMLS CUI [1])
Investigational New Drugs
Item
2. the subject received an imp within 30 days before or is scheduled to receive one during or in the next 30 days after imp administration.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Constituents | Exercise Unable | Medical contraindication Adenosine | Asthmatics
Item
3. the subject has known allergies to any product used in this study or its constituents, including subjects who are not able to exercise and have contraindications to adenosine (e.g., asthmatics).
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0729650 (UMLS CUI [2,3])
C0015259 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0001443 (UMLS CUI [4,2])
C3816164 (UMLS CUI [5])
Disease Serious | Life threatening illness | Life Expectancy
Item
4. the subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3846017 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Medical contraindication Study Procedures | Medical contraindication Exercise | Medical contraindication Myoview | Medical contraindication Thallium-201 | Medical contraindication Adenosine | Medical contraindication Dipyridamole | Second degree atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome | Bradycardia | Bronchoconstriction | Bronchial Spasm
Item
5. the subject has no contraindications to any of the study procedures (e.g. physical exercise) or the involved drugs (myoview, thallium-201, adenosine or dipyridamole) such as e.g. 2nd or 3rd degree av-block, ss syndrome, bradycardia, bronchoconstrictive or bronchospastic lung disease.
boolean
C1301624 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C1948041 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0379804 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0303322 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0001443 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0012582 (UMLS CUI [6,2])
C0264906 (UMLS CUI [7])
C0151517 (UMLS CUI [8])
C0037052 (UMLS CUI [9])
C0428977 (UMLS CUI [10])
C0079043 (UMLS CUI [11])
C0006266 (UMLS CUI [12])
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