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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00628524
Other study ID # HCS Study
Secondary ID
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


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
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