Prognosis of Type 2 Diabetic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01426685
• Date of registration: 16/08/2011
• Prospective Registration: No
• Primary sponsor: University of Oulu
• Public title: Prognosis of Type 2 Diabetic Patients ARTEMIS
• Scientific title: Prediction of Cardiovascular Events in Type 2 Diabetic Patients With Coronary Artery Disease- Application of Novel Risk Markers and Technology
• Date of first enrolment: August 2007
• Target sample size: 1880
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01426685
• Study type: Observational

Countries of recruitment

Finland

Contacts

• Name: Heikki V Huikuri, MD
• Affiliation: University of Oulu

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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:

1. sex (1:1)

2. age (<40 years, 40-50 years, 50-60 years, 60-70 years, 70-80 years)

3. history of recent (<3 months) myocardial infarction (1:1)

4. type of coronary intervention after angiography (1:1 CABG ).

- 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. -

- 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).

Exclusion Criteria:

- • NYHA class IV despite appropriate treatment of heart failure;

- Planned ICD implantation;

- Participation in a competing clinical trial that is not accepted by the Steering
Committee;

- Psychologically or physically (due to any other illness) unfit for participation
in the study according to the opinion of the investigator;

- Patient compliance doubtful;

- Patients who are geographically or otherwise inaccessible for follow-up;

- Pregnancy;

- Life expectancy < 1 year;

- end-stage renal failure needing dialysis

- age < 18 years, or > 80 years

- permanent pacemaker or implantable cardioverter-defibrillator



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cardiovascular Risk Assessment

Primary Outcome(s)

sudden cardiac death [Time Frame: 2007-2017 (up to ten years)]

Secondary Outcome(s)

cardiovascular mortality [Time Frame: 2007-2017 (up to ten years)]

non-fatal cardiovascular event [Time Frame: 2007-2017 (up to ten years)]

Secondary ID(s)

1539/31/06

40042/07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Finnish Funding Agency for Technology and Innovation (TEKES)