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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010356-97 | EudraCT Number |
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| Name | Class |
|---|---|
| University Hospital, Saarland | OTHER |
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Non-fasting triglyceride levels are thought to play a role in stroke. The investigators hypothesise that the results of a standardised oral triglyceride tolerance test in the subacute setting (3-7 days) after the first ischaemic stroke are associated with the risk of recurrent stroke within 12 months after the index event.
Since high postprandial triglycerides levels may be a risk factor for stroke, we use a combined oral triglyceride and glucose tolerance test in patients who had a first ischemic stroke. Follow-up after one year primarily assesses wether or not a recurrent stroke has occured. The glucose tolerance test is meant to identify patients with metabolic syndrome (and diabetes), since this condition is per se associated with increased levels of triglycerides. Potentially, the post-challenge triglyceride levels only play a role in patients without diabetes or metabolic syndrome. For further details see Ebinger et al. 'The Berlin 'Cream&Sugar' Study: the prognostic impact of an oral triglyceride tolerance test in patients after acute ischaemic stroke', IJS; 2010,5, 47-51.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with first ischemic stroke |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test) | Other | see Ebinger et al., IJS, 2010 |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Stroke | The primary end-point of the study is a recurrent fatal or nonfatal stroke within the first 12 months after the event. | outcome measure is assessed one year after first ischemic stroke. |
| Measure | Description | Time Frame |
|---|---|---|
| MI | Myocardial infarction | one year after first ischemic stroke |
| death | cardiovascular death (death due to any cardiovascular or cerebrovascular event) |
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Inclusion Criteria:
Exclusion Criteria:
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the study population consists of adults with first ischemic stroke within the last three to seven days (at time of testing).
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| Name | Affiliation | Role |
|---|---|---|
| Martin Ebinger | Clínica Sebastián de Belalcázar | Principal Investigator |
| Matthias Endres | Clínica Sebastián de Belalcázar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20446947 | Background | Ebinger M, Heuschmann PU, Jungehuelsing GJ, Werner C, Laufs U, Endres M. The Berlin 'Cream&Sugar' Study: the prognostic impact of an oral triglyceride tolerance test in patients after acute ischaemic stroke. Int J Stroke. 2010 Apr;5(2):126-30. doi: 10.1111/j.1747-4949.2010.00399.x. | |
| 27856951 | Derived | Lange KS, Nave AH, Liman TG, Grittner U, Endres M, Ebinger M. Lipoprotein(a) Levels and Recurrent Vascular Events After First Ischemic Stroke. Stroke. 2017 Jan;48(1):36-42. doi: 10.1161/STROKEAHA.116.014436. Epub 2016 Nov 17. |
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| one year after first ischemic stroke |
| TIA | transient ischemic attack | one year after first ischemic stroke |
| 26398290 | Derived | Batluk J, Leonards CO, Grittner U, Lange KS, Schreiber SJ, Endres M, Ebinger M. Triglycerides and carotid intima-media thickness in ischemic stroke patients. Atherosclerosis. 2015 Nov;243(1):186-91. doi: 10.1016/j.atherosclerosis.2015.09.003. Epub 2015 Sep 9. |
| 22935398 | Derived | Leonards CO, Ipsen N, Malzahn U, Fiebach JB, Endres M, Ebinger M. White matter lesion severity in mild acute ischemic stroke patients and functional outcome after 1 year. Stroke. 2012 Nov;43(11):3046-51. doi: 10.1161/STROKEAHA.111.646554. Epub 2012 Aug 30. |