CClinicalTrials.gg
Sign In
Status unknownNCT01426685ARTEMISUpdated Apr 19, 2019

Prognosis of Type 2 Diabetic Patients

An observational study in Cardiovascular Risk Assessment, sponsored by University of Oulu. Status unknown at 1 site in Finland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by University of Oulu · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,880
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.
  1. 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
02

Conditions studied

  • Cardiovascular Risk Assessment

Keywords

  • sudden death
  • coronary artery disease
  • diabetes
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 1,880 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,880 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. sudden cardiac death

    Death occuurring within one hour after onset of symptoms, or within 24 hours when the patient has last seen alive

    Time frame: 2007-2017 (up to ten years)

Secondary outcomes

  1. cardiovascular mortality

    Sudden and non-sudden cardiac death, stroke mortality

    Time frame: 2007-2017 (up to ten years)

  2. non-fatal cardiovascular event

    acute coronary event, myocardial infarction, congestive heart failure, or stroke needing hospitalization

    Time frame: 2007-2017 (up to ten years)

07

Study locations

1 site
  • University of Oulu
    Oulu, 90014, Finland
08

References and documents

Publications

  • Tulppo MP, Kiviniemi AM, Lahtinen M, Ukkola O, Toukola T, Perkiomaki J, Junttila MJ, Huikuri HV. Physical Activity and the Risk for Sudden Cardiac Death in Patients With Coronary Artery Disease. Circ Arrhythm Electrophysiol. 2020 Jun;13(6):e007908. doi: 10.1161/CIRCEP.119.007908. Epub 2020 May 20. PubMed 32433894 ↗
  • Kiviniemi AM, Tulppo MP, Junttila MJ, Huikuri HV. Response to Comment on Kiviniemi et al. Prediabetes and Risk for Cardiac Death Among Patients With Coronary Artery Disease: The ARTEMIS Study. Diabetes Care 2019;42:1319-1325. Diabetes Care. 2019 Dec;42(12):e195. doi: 10.2337/dci19-0050. No abstract available. PubMed 31748220 ↗
  • Kiviniemi AM, Lepojarvi ES, Tulppo MP, Piira OP, Kentta TV, Perkiomaki JS, Ukkola OH, Myerburg RJ, Junttila MJ, Huikuri HV. Prediabetes and Risk for Cardiac Death Among Patients With Coronary Artery Disease: The ARTEMIS Study. Diabetes Care. 2019 Jul;42(7):1319-1325. doi: 10.2337/dc18-2549. Epub 2019 May 10. PubMed 31076416 ↗
  • Puurunen VP, Lepojarvi ES, Piira OP, Hedberg P, Junttila MJ, Ukkola O, Huikuri HV. High plasma leptin levels are associated with impaired diastolic function in patients with coronary artery disease. Peptides. 2016 Oct;84:17-21. doi: 10.1016/j.peptides.2016.08.002. Epub 2016 Aug 11. PubMed 27524739 ↗
  • Lepojarvi ES, Piira OP, Kiviniemi AM, Miettinen JA, Kentta T, Ukkola O, Tulppo MP, Huikuri HV, Junttila MJ. Usefulness of Highly Sensitive Troponin as a Predictor of Short-Term Outcome in Patients With Diabetes Mellitus and Stable Coronary Artery Disease (from the ARTEMIS Study). Am J Cardiol. 2016 Feb 15;117(4):515-521. doi: 10.1016/j.amjcard.2015.11.038. Epub 2015 Dec 6. PubMed 26739392 ↗
  • Kiviniemi AM, Lepojarvi S, Kentta TV, Junttila MJ, Perkiomaki JS, Piira OP, Ukkola O, Hautala AJ, Tulppo MP, Huikuri HV. Exercise capacity and heart rate responses to exercise as predictors of short-term outcome among patients with stable coronary artery disease. Am J Cardiol. 2015 Nov 15;116(10):1495-501. doi: 10.1016/j.amjcard.2015.08.014. Epub 2015 Aug 31. PubMed 26381535 ↗
  • Karjalainen JJ, Kiviniemi AM, Hautala AJ, Piira OP, Lepojarvi ES, Perkiomaki JS, Junttila MJ, Huikuri HV, Tulppo MP. Effects of physical activity and exercise training on cardiovascular risk in coronary artery disease patients with and without type 2 diabetes. Diabetes Care. 2015 Apr;38(4):706-15. doi: 10.2337/dc14-2216. Epub 2015 Jan 15. PubMed 25592198 ↗
  • Perkiomaki J, Exner DV, Piira OP, Kavanagh K, Lepojarvi S, Talajic M, Karvonen J, Philippon F, Junttila J, Coutu B, Huikuri H. Heart Rate Turbulence and T-Wave Alternans in Patients with Coronary Artery Disease: The Influence of Diabetes. Ann Noninvasive Electrocardiol. 2015 Sep;20(5):481-7. doi: 10.1111/anec.12244. Epub 2015 Jan 15. PubMed 25589197 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01426685
Lead sponsor
University of Oulu
Collaborators
The Finnish Funding Agency for Technology and Innovation (TEKES)
Responsible party
Sponsor
First posted
Aug 31, 2011
Start date
Aug 2007
Primary completion
Jun 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Apr 19, 2019

Study contacts

Heikki V Huikuri, MD
principal investigator · University of Oulu

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Coronary Artery Disease→

Other studies from this sponsor

University of Oulu

Start the discussion