Homburg Cream & Sugar Study - Full Text View

Sponsored by:	University Hospital, Saarland
Information provided by:	University Hospital, Saarland
ClinicalTrials.gov Identifier:	NCT00628524

Purpose

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

Condition
Coronary Artery Disease Diabetes Glucose Tolerance Hyperlipidemia

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prospective Investigation of the Influence of Triglyceride Tolerance on Cardiovascular Outcomes in Patients With Coronary Artery Disease

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:

Parameters of triglyceride tolerance and glucose tolerance in correlation to cardiovascular events, cardiovascular mortality, total mortality. [ Time Frame: 6 and 12 months after inclusion. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Waist-to-Hip ratio, nutrition protocol, physical activity, non-invasive endothelial function, non-invasive hepatic fat content, body fat composition. [ Time Frame: Directly after inclusion. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum

Estimated Enrollment:	500
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 > 500 consecutive patients with coronary artery disease fulfilling eligibility criteria.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

Stable CAD

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628524

Contacts

Contact: Ulrich Laufs, MD	+496841162 ext 1331	ulrich@laufs.com
Contact: Michael Böhm, Prof	+496841162 ext 3372	boehm@uks.eu

Locations

Germany, Saarland
University Hospital Homburg / Saar - Cardiology Department	Recruiting
Homburg, Saarland, Germany, 66421
Contact: Ulrich Laufs, MD +496841162 ext 1331 ulrich@laufs.com
Contact: Christian M Werner, MD +496841162 ext 3436 cwerner@med-in.uni-saarland.de
Principal Investigator: Ulrich Laufs, MD
Sub-Investigator: Christian M Werner, MD

Sponsors and Collaborators

University Hospital, Saarland

Investigators

Principal Investigator:

Ulrich Laufs, MD

University Hospital, Saarland

More Information

No publications provided

Responsible Party:	University Hospital of Saarland, Internal Medicine III - Cardiology, Angiology, Internal Medicine ICU ( PD Dr. Ulrich Laufs )
Study ID Numbers:	HCS Study
Study First Received:	February 25, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00628524 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Arterial Occlusive Diseases
Hyperlipidemias
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Diabetes Mellitus
Vascular Diseases

Ischemia
Arteriosclerosis
Coronary Disease
Metabolic Disorder
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Metabolic Diseases
Heart Diseases
Hyperlipidemias
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Dyslipidemias
Coronary Artery Disease
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009