The Role of OXytocin in Acute Ischemic Stroke reconvAlesceNcE: The ROXANE Study

Acute Ischemic Stroke Clinical Trial

— ROXANE  

Official title:

The Role of OXytocin in Acute Ischemic Stroke reconvAlesceNcE: The ROXANE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873309
• Other study ID #: 2023-00608; ko23katan
• Status: Recruiting
• Start date: April 26, 2023
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Johannes Frenger, Dr. med.
• Phone: +41613284612
• Email: johannes.frenger[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Rapid onset of a focal neurologic deficit, with signs or symptoms persisting beyond 24 hours and not associated with infection, trauma, or tumor of the brain, severe metabolic disorders, or chronic degenerative neurologic disease; or

• the development of an acute focal neurologic deficit persisting >24 hours in conjunction with brain imaging consistent with acute ischemic stroke. The CT or MRI may either show a new infarct or no change from the study performed at entry, i.e., the diagnosis is clinical and does not require CT/MRI confirmation. Secondary hemorrhagic infarction is permissible.

• First blood sample at the stroke unit is taken within 24 hours from symptom onset.

Exclusion Criteria:

• Patients below 18 years

• Hemorrhagic stroke or patients discharged from the hospital with a diagnosis different from ischemic stroke (i.e., stroke mimics)

• Missing informed consent

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss Academy of Medical Sciences (SAMS)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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