ID

16962

Description

Non Invasive Multicenter Italian Study for Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00539604

Link

https://clinicaltrials.gov/show/NCT00539604

Keywords

Versions (1)
  1. 8/16/16 8/16/16 -
Uploaded on

August 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00539604

English

Eligibility Coronary Heart Disease NCT00539604

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients (men or women of any ethnic group) scheduled for a coronary angiography evaluation for a diagnostic work up.
Description

Gender | Ethnic group Any | Coronary angiography Evaluation work up

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0015031
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C0085532
UMLS CUI [3,2]
C0220825
UMLS CUI [3,3]
C0750430
2. patients will be expected to undergo coronary angiography within 2 weeks after the mdct study procedure. the coronary angiography must meet the minimum standard laid down in the protocol (see section 8.3.3).
Description

Coronary angiography | multidetector computed tomography Study

Data type

boolean

Alias
UMLS CUI [1]
C0085532
UMLS CUI [2,1]
C2106966
UMLS CUI [2,2]
C2603343
3. patients must have hdl and total cholesterol performed within the last year.
Description

Serum HDL cholesterol measurement | Serum total cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428472
UMLS CUI [2]
C1445957
4. patients must be willing and able to continue study participation following the reference test to ensure completion of all procedures and observations required by the study.
Description

Study Subject Participation Status | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0525058
5. fully informed and signed consent must be obtained from each patient.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients under 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients who have received any investigational drug within the 30 days prior to entering this study.
Description

Investigational New Drug Received

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1514756
3. pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. patients who have any contraindication to mdct examination with iodinate contrast media.
Description

Medical contraindication multidetector computed tomography Iodinated contrast media

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2106966
UMLS CUI [1,3]
C1960405
5. patients with heart rate >70 bpm despite of β-blocker treatment (see section 8.2.4.1).
Description

heart rate | Adrenergic beta-Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0001645
6. patients with no sinus rhythm.
Description

Sinus rhythm

Data type

boolean

Alias
UMLS CUI [1]
C0232201
7. patients with nyha iii or iv class.
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
8. patients who have previously undergone cabg or stenting.
Description

Coronary Artery Bypass Surgery | Stenting

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C2348535
9. patients with a creatinine value > 2 mg/dl.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
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Similar models

Eligibility Coronary Heart Disease NCT00539604

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Ethnic group Any | Coronary angiography Evaluation work up
Item
1. patients (men or women of any ethnic group) scheduled for a coronary angiography evaluation for a diagnostic work up.
boolean
C0079399 (UMLS CUI [1])
C0015031 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0085532 (UMLS CUI [3,1])
C0220825 (UMLS CUI [3,2])
C0750430 (UMLS CUI [3,3])
Coronary angiography | multidetector computed tomography Study
Item
2. patients will be expected to undergo coronary angiography within 2 weeks after the mdct study procedure. the coronary angiography must meet the minimum standard laid down in the protocol (see section 8.3.3).
boolean
C0085532 (UMLS CUI [1])
C2106966 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
Serum HDL cholesterol measurement | Serum total cholesterol measurement
Item
3. patients must have hdl and total cholesterol performed within the last year.
boolean
C0428472 (UMLS CUI [1])
C1445957 (UMLS CUI [2])
Study Subject Participation Status | Protocol Compliance
Item
4. patients must be willing and able to continue study participation following the reference test to ensure completion of all procedures and observations required by the study.
boolean
C2348568 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Informed consent
Item
5. fully informed and signed consent must be obtained from each patient.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. patients under 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Investigational New Drug Received
Item
2. patients who have received any investigational drug within the 30 days prior to entering this study.
boolean
C0013230 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
3. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical contraindication multidetector computed tomography Iodinated contrast media
Item
4. patients who have any contraindication to mdct examination with iodinate contrast media.
boolean
C1301624 (UMLS CUI [1,1])
C2106966 (UMLS CUI [1,2])
C1960405 (UMLS CUI [1,3])
heart rate | Adrenergic beta-Antagonists
Item
5. patients with heart rate >70 bpm despite of β-blocker treatment (see section 8.2.4.1).
boolean
C0018810 (UMLS CUI [1])
C0001645 (UMLS CUI [2])
Sinus rhythm
Item
6. patients with no sinus rhythm.
boolean
C0232201 (UMLS CUI [1])
New York Heart Association Classification
Item
7. patients with nyha iii or iv class.
boolean
C1275491 (UMLS CUI [1])
Coronary Artery Bypass Surgery | Stenting
Item
8. patients who have previously undergone cabg or stenting.
boolean
C0010055 (UMLS CUI [1])
C2348535 (UMLS CUI [2])
Creatinine measurement, serum
Item
9. patients with a creatinine value > 2 mg/dl.
boolean
C0201976 (UMLS CUI [1])
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