Homburg Cream & Sugar Study

Coronary Artery Disease Clinical Trial

— HCS  

Official title:

Prospective Investigation of the Influence of Triglyceride Tolerance on Cardiovascular Outcomes in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628524
• Other study ID #: HCS Study
• Status: Completed
• Phase: N/A
• First received: February 25, 2008
• Last updated: December 6, 2013
• Start date: February 2008
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Glucose Tolerance
• Hyperlipidemia
• Hyperlipidemias
• Metabolic Syndrome
• Metabolic Syndrome X
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	University Hospital Homburg / Saar - Cardiology Department	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters of triglyceride tolerance and glucose tolerance in correlation to cardiovascular events, cardiovascular mortality, total mortality.		48 months after inclusion.	No
Secondary	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.	No