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Cardiovascular Risk AssessmentARTEMISNCT01426685

Prognosis of Type 2 Diabetic Patients

An observational study of Cardiovascular Risk Assessment, run by University of Oulu at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cardiovascular Risk Assessment
How many people
1,880 participants
Where
1 siteFinland
Study dates
Aug 2007to Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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).

Who cannot join

  • • 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;
Show all 11Show fewer
  • Pregnancy;
  • Life expectancy < 1 year;
  • end-stage renal failure needing dialysis
  • age < 18 years, or > 80 years
  • permanent pacemaker or implantable cardioverter-defibrillator

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • University of Oulu

    Oulu, 90014

Other trials in Finland

About this study

Official title: 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.

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.
  6. 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
Keywords
sudden death, coronary artery disease, diabetes
Medical subject headings
Death, Sudden, Coronary Artery Disease, Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sudden cardiac death

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

    Measured: 2007-2017 (up to ten years)

Secondary outcomes (2)

  1. cardiovascular mortality

    Sudden and non-sudden cardiac death, stroke mortality

    Measured: 2007-2017 (up to ten years)

  2. non-fatal cardiovascular event

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

    Measured: 2007-2017 (up to ten years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2011 (estimated)
  2. Study startAug 2007
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,880 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01426685
Sponsor's protocol ID
1539/31/06
Other IDs
40042/07
Acronym
ARTEMIS
Status last verified
Apr 2019
First submitted
16 Aug 2011
Last updated
19 Apr 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38390795

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Risk Assessment, run by University of Oulu at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sudden cardiac death (time frame: 2007-2017 (up to ten years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01426685, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.

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