NCT00628524

Brief Summary

The purpose of this study is to prospectivly analyze the correlation of triglyceride tolerance and glucose tolerance with cardiovascular morbidity and mortality in patients with stable coronary artery disease within 18 months and to determine, whether measurement of triglyceride tolerance can discriminate patients at risk for cardiovascular events.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
514

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 2, 2025

Status Verified

December 1, 2013

Enrollment Period

5.4 years

First QC Date

February 25, 2008

Last Update Submit

November 24, 2025

Conditions

Coronary Artery DiseaseDiabetesMetabolic SyndromeGlucose ToleranceHyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Parameters of triglyceride tolerance and glucose tolerance in correlation to cardiovascular events, cardiovascular mortality, total mortality.

    48 months after inclusion.

Secondary Outcomes (1)

  • Waist-to-Hip ratio, nutrition protocol, physical activity, non-invasive endothelial function, body fat composition, other biomarkers of lipid and glucose metabolism.

    Directly after inclusion.

Study Arms (1)

1

\> 500 consecutive patients with coronary artery disease fulfilling eligibility criteria.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

\> 500 consecutive patients with stable coronary artery disease being treated in the cardiology department of the university hospital.

You may qualify if:

  • Stable CAD

You may not qualify if:

  • Acute Coronary Syndrom
  • Relevant Arrhythmias
  • Severe valvular heart disease
  • Decompensated heart failure
  • Severe inflammtory disease (infectious, rheumatoid)
  • Metabolic diseases (e.g. thyroid)
  • Inability to swallow
  • Liver or kidney failure
  • Lactose intolerance
  • Fat intolerance (e.g. chronic pancreatitis, gall stones)
  • Malignant Disease
  • Psychiatric Diseases (including alcohol / drug abuse)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Homburg / Saar - Cardiology Department

Homburg, Saarland, 66421, Germany

Location

Related Publications (3)

  • Werner C, Filmer A, Fritsch M, Groenewold S, Graber S, Bohm M, Laufs U. Risk prediction with triglycerides in patients with stable coronary disease on statin treatment. Clin Res Cardiol. 2014 Dec;103(12):984-97. doi: 10.1007/s00392-014-0740-0. Epub 2014 Jul 11.

    PMID: 25012240RESULT

  • Katzmann JL, Werner CM, Stojakovic T, Marz W, Scharnagl H, Laufs U. Apolipoprotein CIII predicts cardiovascular events in patients with coronary artery disease: a prospective observational study. Lipids Health Dis. 2020 May 30;19(1):116. doi: 10.1186/s12944-020-01293-9.

    PMID: 32473635DERIVED

  • Hoffmann MM, Werner C, Bohm M, Laufs U, Winkler K. Association of secreted frizzled-related protein 4 (SFRP4) with type 2 diabetes in patients with stable coronary artery disease. Cardiovasc Diabetol. 2014 Nov 19;13:155. doi: 10.1186/s12933-014-0155-2.

    PMID: 25408147DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes MellitusMetabolic SyndromeHyperlipidemias

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinismDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Ulrich Laufs, MD

    University Hospital, Saarland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

December 2, 2025

Record last verified: 2013-12

Locations

DE(1)