ID

27500

Description

Prognosis of Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01426685

Link

https://clinicaltrials.gov/show/NCT01426685

Keywords

Versions (1)
  1. 11/18/17 11/18/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 18, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Devices Associated With Adverse Incidents, Diagnostic and Monitoring Devices NCT01426685

English

Eligibility Cardiovascular Devices Associated With Adverse Incidents, Diagnostic and Monitoring Devices NCT01426685

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a total of 1200 patients with cad and diagnosed type ii diabetes and 600 patients with cad but without evidence of diabetes will be included in the study. the patients will be recruited from the consecutive series of patients undergoing coronary angiography in the division of cardiology of the oulu university hospital. first, 600 patients with diabetes will be collected. thereafter, 600 matched cad patients without diabetes will be recruited. the groups will be matched in terms of following variables:
Description

Patients Quantity | Coronary Artery Disease | Diabetes Mellitus, Non-Insulin-Dependent | Coronary angiography | Groups MATCHING

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0011860
UMLS CUI [4]
C0085532
UMLS CUI [5,1]
C0441833
UMLS CUI [5,2]
C0150103
1. sex (1:1)
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
2. age (<40 years, 40-50 years, 50-60 years, 60-70 years, 70-80 years)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. history of recent (<3 months) myocardial infarction (1:1)
Description

Myocardial Infarction Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0332185
4. type of coronary intervention after angiography (1:1 cabg ).
Description

Type Intervention Coronary | Status post Angiography | CABG

Data type

boolean

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C1522318
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0002978
UMLS CUI [3]
C0010055
diabetes is defined as fasting plasma glucose levels ≥ 7.0 and/or a 2-h postload value in the ogtt 11.1 mmol/l according to definition and diagnosis of diabetes mellitus and intermediate hyperglycemia : report of a who/idf consultation. world health organization (who) 2006. -
Description

Diabetes Mellitus | Plasma fasting glucose measurement | Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0583513
UMLS CUI [3]
C0029161
patients without a diabetes must be normoglycemic defined as plasma glucose levels <6.1 mmol/l in the fasting state and a 2-h postload value < 7.8 mmol/l in the oral glucose tolerance test (ogtt).
Description

Diabetes Mellitus Absent | Plasma fasting glucose measurement | Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0583513
UMLS CUI [3]
C0029161
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
• nyha class iv despite appropriate treatment of heart failure;
Description

New York Heart Association Classification | Therapeutic procedure Appropriate Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0018801
planned icd implantation;
Description

ICD Implantation Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C1301732
participation in a competing clinical trial that is not accepted by the steering committee;
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
psychologically or physically (due to any other illness) unfit for participation in the study according to the opinion of the investigator;
Description

Study Subject Participation Status Psychologically unfit Due to Illness | Study Subject Participation Status Physically unfit Due to Illness

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3841804
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0221423
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0850765
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0221423
patient compliance doubtful;
Description

Compliance behavior Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0750558
patients who are geographically or otherwise inaccessible for follow-up;
Description

Patient unavailable Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C3274571
pregnancy;
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
life expectancy < 1 year;
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
end-stage renal failure needing dialysis
Description

Chronic Kidney Failure Requirement Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
age < 18 years, or > 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
permanent pacemaker or implantable cardioverter-defibrillator
Description

Permanent pacemaker | ICD Permanent

Data type

boolean

Alias
UMLS CUI [1]
C0281945
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0205355
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Similar models

Eligibility Cardiovascular Devices Associated With Adverse Incidents, Diagnostic and Monitoring Devices NCT01426685

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients Quantity | Coronary Artery Disease | Diabetes Mellitus, Non-Insulin-Dependent | Coronary angiography | Groups MATCHING
Item
a total of 1200 patients with cad and diagnosed type ii diabetes and 600 patients with cad but without evidence of diabetes will be included in the study. the patients will be recruited from the consecutive series of patients undergoing coronary angiography in the division of cardiology of the oulu university hospital. first, 600 patients with diabetes will be collected. thereafter, 600 matched cad patients without diabetes will be recruited. the groups will be matched in terms of following variables:
boolean
C0030705 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
C0085532 (UMLS CUI [4])
C0441833 (UMLS CUI [5,1])
C0150103 (UMLS CUI [5,2])
Gender
Item
1. sex (1:1)
boolean
C0079399 (UMLS CUI [1])
Age
Item
2. age (<40 years, 40-50 years, 50-60 years, 60-70 years, 70-80 years)
boolean
C0001779 (UMLS CUI [1])
Myocardial Infarction Recent
Item
3. history of recent (<3 months) myocardial infarction (1:1)
boolean
C0027051 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Type Intervention Coronary | Status post Angiography | CABG
Item
4. type of coronary intervention after angiography (1:1 cabg ).
boolean
C0332307 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C1522318 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0002978 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3])
Diabetes Mellitus | Plasma fasting glucose measurement | Oral Glucose Tolerance Test
Item
diabetes is defined as fasting plasma glucose levels ≥ 7.0 and/or a 2-h postload value in the ogtt 11.1 mmol/l according to definition and diagnosis of diabetes mellitus and intermediate hyperglycemia : report of a who/idf consultation. world health organization (who) 2006. -
boolean
C0011849 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
C0029161 (UMLS CUI [3])
Diabetes Mellitus Absent | Plasma fasting glucose measurement | Oral Glucose Tolerance Test
Item
patients without a diabetes must be normoglycemic defined as plasma glucose levels <6.1 mmol/l in the fasting state and a 2-h postload value < 7.8 mmol/l in the oral glucose tolerance test (ogtt).
boolean
C0011849 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0583513 (UMLS CUI [2])
C0029161 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
New York Heart Association Classification | Therapeutic procedure Appropriate Heart failure
Item
• nyha class iv despite appropriate treatment of heart failure;
boolean
C1275491 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,3])
ICD Implantation Planned
Item
planned icd implantation;
boolean
C0162589 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Study Subject Participation Status
Item
participation in a competing clinical trial that is not accepted by the steering committee;
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Psychologically unfit Due to Illness | Study Subject Participation Status Physically unfit Due to Illness
Item
psychologically or physically (due to any other illness) unfit for participation in the study according to the opinion of the investigator;
boolean
C2348568 (UMLS CUI [1,1])
C3841804 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0221423 (UMLS CUI [1,4])
C2348568 (UMLS CUI [2,1])
C0850765 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0221423 (UMLS CUI [2,4])
Compliance behavior Unlikely
Item
patient compliance doubtful;
boolean
C1321605 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Patient unavailable Follow-up
Item
patients who are geographically or otherwise inaccessible for follow-up;
boolean
C1301818 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Life Expectancy
Item
life expectancy < 1 year;
boolean
C0023671 (UMLS CUI [1])
Chronic Kidney Failure Requirement Dialysis
Item
end-stage renal failure needing dialysis
boolean
C0022661 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
Age
Item
age < 18 years, or > 80 years
boolean
C0001779 (UMLS CUI [1])
Permanent pacemaker | ICD Permanent
Item
permanent pacemaker or implantable cardioverter-defibrillator
boolean
C0281945 (UMLS CUI [1])
C0162589 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
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