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| Name | Class |
|---|---|
| Swiss Academy of Medical Sciences (SAMS) | OTHER |
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Evidence suggests that oxytocin has a neuroprotective role on a systemic and cellular level in the context of acute ischemic stroke (AIS). The investigators therefore hypothesize that high levels of circulating oxytocin measured within the first 72 hours after symptom onset are associated with lower mortality and favorable outcome in acute ischemic stroke.
The preliminary data suggest a possible neuroprotective role of oxytocin via endocrine as well as paracrine effects, underscoring that oxytocin levels in the acute phase of stroke may have a considerable influence on patient outcomes. However, the role of oxytocin in acute ischemic stroke patients has, to our knowledge, never been investigated. If oxytocin really shows a strong associated with functional outcomes after stroke and given the fact that commercially available oxytocin can be safely administered via nasal spray, oxytocin would become an innovative and highly interesting novel therapeutic agent for ischemic stroke patients in the near future. For the ROXANE cohort the investigators plan to recruit patients with acute ischemic stroke from the University Hospital in Basel. The study is designed as an observational cohort study, because an observational study is currently at this stage of knowledge (effect of oxytocin in vitro and in vivo (animal models)), the best study design. It harbors minimal harm, but still allows us to adequately estimate the association of oxytocin levels in humans with stroke outcome. If it is possible to establish this association in humans based on results of the planned observation study, the investigators will be able to plan an interventional trial, which may directly beneficially impact clinical outcome of stroke patient.
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| Measure | Description | Time Frame |
|---|---|---|
| 90-day mortality Rate | The 90-day mortality rate will be assessed via a structured telephone interview on day 90 (+/- 10) | 90 days after stroke |
| 90-day functional outcome | The 90-day functional outcome will be assessed with the modified Ranking Scale (mRS) via a structured telephone interview on day 90 (+/- 10). The modified Ranking Scale is a 6 point disability scale with possible scores ranging from 0 to 5. 0= no symptoms, 5 = severe disability. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. A favorable outcome is defined as a mRS score of 0 to 2 points. | 90 days after stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of post-stroke symptoms | Patient Health Questionnaire-9 (PHQ-9) will be assessed via a structured telephone interview. The PHQ-9 is scored 0 to 27, with scores >/= 10 indicating a possible depressive disorder. | 90 days after stroke |
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Inclusion Criteria:
Exclusion Criteria:
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For the ROXANE cohort the investigators plan to recruit patients with acute ischemic stroke from the University Hospital in Basel.
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Frenger, Dr. med. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Blood samples
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |