Prognosis of Type 2 Diabetic Patients
ARTEMIS
Prediction of Cardiovascular Events in Type 2 Diabetic Patients With Coronary Artery Disease- Application of Novel Risk Markers and Technology
2 other identifiers
observational
1,880
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 16, 2011
CompletedFirst Posted
Study publicly available on registry
August 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedApril 19, 2019
April 1, 2019
11.8 years
August 16, 2011
April 18, 2019
Conditions
Keywords
Outcome Measures
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
2007-2017 (up to ten years)
Secondary Outcomes (2)
cardiovascular mortality
2007-2017 (up to ten years)
non-fatal cardiovascular event
2007-2017 (up to ten years)
Eligibility Criteria
1200 diabetic patients with coronary artery disease and 600 non-diabetic patients with coronary artery disease.
You may qualify if:
- 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:
- sex (1:1)
- age (\<40 years, 40-50 years, 50-60 years, 60-70 years, 70-80 years)
- history of recent (\<3 months) myocardial infarction (1:1)
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oulu
Oulu, 90014, Finland
Related Publications (9)
Rahunen R, Tulppo M, Rinne V, Lepojarvi S, Perkiomaki JS, Huikuri HV, Ukkola O, Junttila J, Hukkanen J. Liver X Receptor Agonist 4beta-Hydroxycholesterol as a Prognostic Factor in Coronary Artery Disease. J Am Heart Assoc. 2024 Mar 5;13(5):e031824. doi: 10.1161/JAHA.123.031824. Epub 2024 Feb 23.
PMID: 38390795DERIVEDTulppo 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.
PMID: 32433894DERIVEDKiviniemi 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.
PMID: 31748220DERIVEDKiviniemi 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.
PMID: 31076416DERIVEDPuurunen 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.
PMID: 27524739DERIVEDLepojarvi 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.
PMID: 26739392DERIVEDKiviniemi 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.
PMID: 26381535DERIVEDKarjalainen 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.
PMID: 25592198DERIVEDPerkiomaki 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.
PMID: 25589197DERIVED
Biospecimen
Blood samples are stored for analysis of various biomarkers and for extracting DNAs.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heikki V Huikuri, MD
University of Oulu
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2011
First Posted
August 31, 2011
Study Start
August 1, 2007
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
April 19, 2019
Record last verified: 2019-04