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

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StudyEvent: Eligibility
1. Eligibility Cardiovascular Devices Associated With Adverse Incidents, Diagnostic and Monitoring Devices NCT01426685

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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