Prognosis of Type 2 Diabetic Patients (ARTEMIS)

April 18, 2019 updated by: University of Oulu

Prediction of Cardiovascular Events in Type 2 Diabetic Patients With Coronary Artery Disease- Application of Novel Risk Markers and Technology

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.

Study Overview

Status

Unknown

Conditions

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

Study Type

Observational

Enrollment (Actual)

1880

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90014
        • University of Oulu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sudden cardiac death
Time Frame: 2007-2017 (up to ten years)
Death occuurring within one hour after onset of symptoms, or within 24 hours when the patient has last seen alive
2007-2017 (up to ten years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular mortality
Time Frame: 2007-2017 (up to ten years)
Sudden and non-sudden cardiac death, stroke mortality
2007-2017 (up to ten years)
non-fatal cardiovascular event
Time Frame: 2007-2017 (up to ten years)
acute coronary event, myocardial infarction, congestive heart failure, or stroke needing hospitalization
2007-2017 (up to ten years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

The Finnish Funding Agency for Technology and Innovation (TEKES)

Investigators

  • Principal Investigator: Heikki V Huikuri, MD, University of Oulu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2007

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

August 31, 2011

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1539/31/06
  • 40042/07 (Other Identifier: Finnish Funding Agency for Technology and Innovation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Risk Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe