Homburg Cream & Sugar Study (HCS)
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital, Saarland
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00628524
First received: February 25, 2008
Last updated: July 19, 2011
Last verified: July 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 25, 2008 | ||||
| Last Updated Date | July 19, 2011 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Parameters of triglyceride tolerance and glucose tolerance in correlation to cardiovascular events, cardiovascular mortality, total mortality. [ Time Frame: 18 months after inclusion. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00628524 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Waist-to-Hip ratio, nutrition protocol, physical activity, non-invasive endothelial function, body fat composition. [ Time Frame: Directly after inclusion. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Homburg Cream & Sugar Study | ||||
| Official Title ICMJE | Prospective Investigation of the Influence of Triglyceride Tolerance on Cardiovascular Outcomes in Patients With Coronary Artery Disease | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum |
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| Sampling Method | Probability Sample | ||||
| Study Population | > 500 consecutive patients with stable coronary artery disease being treated in the cardiology department of the university hospital. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
> 500 consecutive patients with coronary artery disease fulfilling eligibility criteria. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | August 2011 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00628524 | ||||
| Other Study ID Numbers ICMJE | HCS Study | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof. Dr. Ulrich Laufs, University Hospital of Saarland, Internal Medicine III - Cardiology, Angiology, Internal Medicine ICU | ||||
| Study Sponsor ICMJE | University Hospital, Saarland | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Saarland | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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