Investigating how circadian factors affect recovery after ischemic stroke
The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · NCT05242393
This study is trying to see how sleep patterns and body clock factors affect recovery in people who have had an ischemic stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health (other) |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT05242393 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between circadian rhythm biomarkers and sleep characteristics in acute ischemic stroke patients, assessing their impact on stroke outcomes. It includes a retrospective analysis of data from patients admitted to the stroke unit from 2018 to 2022, as well as a prospective longitudinal evaluation of 200-250 patients. Participants will undergo assessments of medical records, stroke characteristics, sleep patterns, and blood sampling for genetic biomarker analysis within the first few days of admission. The study will evaluate how these factors correlate with neurological and functional recovery over a two-week period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have experienced an acute ischemic stroke within the last day and have moderate to severe stroke severity.
Not a fit: Patients with secondary hemorrhagic strokes, unstable conditions, or known progressive neurological or psychiatric diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how circadian rhythms influence recovery from stroke, potentially leading to improved treatment strategies.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated potential associations between circadian rhythms and recovery outcomes in stroke patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * acute (symptom onset to admission \<1 days) ischemic stroke * ischemic stroke affecting the branches of anterior cerebral artery, middle cerebral artery and posterior cerebral artery * age 18-80 years * moderate or severe stroke (National Institutes of Health Stroke Scale, NIHSS\>=5) * intravascular stroke treatment with thrombolysis or thrombectomy leading to satisfactory reperfusion (if applicable) * informed consent Exclusion Criteria: * secondary parenchymal hemorrhage (\>hemorrhage index -2) * clinically unstable or life-threatening conditions * known progressive neurological diseases * known psychiatric diseases * concomitant benzodiazepine medication * drug or alcohol abuse * pregnancy * disability to participate in the study * congestive heart failure with reduced ejection fraction (\<=45%) or New York Heart Association (NYHA) classification III-IV functional class
Where this trial is running
Saint Petersburg
- Almazov National Medical Research Centre — Saint Petersburg, Russia (RECRUITING)
Study contacts
- Principal investigator: Lyudmila Korostovtseva, MD, PhD — Almazov National Medical Research Centre
- Study coordinator: Lyudmila Korostovtseva, MD, PHD
- Email: lyudmila_korosto@mail.ru
- Phone: +79217873548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Ischemic, Sleep Disorder, neuroplasticity, cognitive dysfunction, disability, circadian rhythm, functional deficit, stroke outcome