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

NCT05873309 | Completed

• 1 other identifier: 2023-00608; ko23katan
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

oxytocin; blood biomarkers

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Assessment of post-stroke symptoms

  90 days after stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

For the ROXANE cohort the investigators plan to recruit patients with acute ischemic stroke from the University Hospital in Basel.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss Academy of Medical Sciences (SAMS): collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Johannes Frenger, Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: April 26, 2023
• Primary Completion: September 23, 2024
• Study Completion: December 31, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)