Prognosis of Type 2 Diabetic Patients (ARTEMIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by University of Oulu
Sponsor:
Collaborator:
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01426685
First received: August 16, 2011
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

The study will include 1200 patients with type 2 diabetes and angiographically documented coronary artery disease and 600 matched non-diabetic patients without type 2 diabetes. Extensive traditional and novel risk marker tests are performed for the patients and they will be followed-up for 5 years. Sudden cardiac death is the main outcome measure and various other endpoints are secondary endpoints. As a substudy, 120 diabetic patients and 120 non-diabetic patients will undergo exercise training with home monitoring to assess the effects of exercise training on risk profiles.


Condition
Cardiovascular Devices Associated With Adverse Incidents, Diagnostic and Monitoring Devices

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Cardiovascular Events in Type 2 Diabetic Patients With Coronary Artery Disease- Application of Novel Risk Markers and Technology

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • sudden cardiac death [ Time Frame: 2007-2017 (up to ten years) ] [ Designated as safety issue: No ]
    Death occuurring within one hour after onset of symptoms, or within 24 hours when the patient has last seen alive


Secondary Outcome Measures:
  • cardiovascular mortality [ Time Frame: 2007-2017 (up to ten years) ] [ Designated as safety issue: No ]
    Sudden and non-sudden cardiac death, stroke mortality

  • non-fatal cardiovascular event [ Time Frame: 2007-2017 (up to ten years) ] [ Designated as safety issue: No ]
    acute coronary event, myocardial infarction, congestive heart failure, or stroke needing hospitalization


Biospecimen Retention:   Samples With DNA

Blood samples are stored for analysis of various biomarkers and for extracting DNAs.


Estimated Enrollment: 1800
Study Start Date: August 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Specific aims of the study:

  1. To compare several autonomic, electric and metabolic risk markers in a case-control study between the patients with coronary artery disease with and without type II diabetes at the time of diagnosis of CAD.
  2. To assess the prognostic significance of autonomic markers, electrical markers, coronary angiographic markers and metabolic markers in predicting the cardiac events among the CAD patients with and without diabetes
  3. To develop and test the feasibility of home-monitoring of biosignals among the type II diabetic patients with CAD.
  4. To further explore the molecular, cellular and genetic factors that predispose diabetics to cardiovascular diseases.
  5. To develop new methods for the early clinical diagnosis of vulnerable subjects susceptible to the complications of the coronary artery disease in Type 2 diabetes.

5. To assess the effects of controlled exercise training programs to several autonomic, electrical and metabolic risk markers among the type II diabetic patients with CAD

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

1200 diabetic patients with coronary artery disease and 600 non-diabetic patients with coronary artery disease.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426685

Contacts
Contact: Heikki V Huikuri, MD + 358 8 3154108 heikki.huikuri@oulu.fi
Contact: Mikko P Tulppo, PhD +358 405081902 mikko-tulppo@verve.fi

Locations
Finland
University of Oulu Recruiting
Oulu, Finland, 90014
Contact: Heikki V Huikuri, MD    +358 3154108    heikki.huikuri@ioulu.fi   
Contact: Mikko P Tulppo, PhD    +358405081902    mikko.tulppo@verve.fi   
Sub-Investigator: Samuli Lepojärvi, MD         
Sub-Investigator: Mikko P Tulppo, PhD         
Sub-Investigator: Olli-Pekka Piira, MD         
Sub-Investigator: Jarkko Niva, MD         
Sub-Investigator: Jaana Karjalainen, MsC         
Sponsors and Collaborators
University of Oulu
The Finnish Funding Agency for Technology and Innovation (TEKES)
Investigators
Principal Investigator: Heikki V Huikuri, MD University of Oulu
  More Information

No publications provided

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01426685     History of Changes
Other Study ID Numbers: 1539/31/06, 40042/07
Study First Received: August 16, 2011
Last Updated: August 30, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by University of Oulu:
sudden death
coronary artery disease
diabetes

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014