The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational) (NCT05242393) | Clinical Trial Compass
RecruitingNot Applicable
The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)
Russia250 participantsStarted 2018-05-01
Plain-language summary
The study is aimed at the investigation of the association of biomarkers of circadian rhythms with sleep characteristics and stroke outcome in acute stroke patients. It is designed as an observational cohort study with the retrospective and prospective longitudinal arms.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion
Timeframe: From baseline to 14th day after treatment initiation
2
Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14th day after treatment initiation
Timeframe: From baseline to 14th day after treatment initiation
3
Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14th day after treatment initiation
Timeframe: From baseline to 14th day after treatment initiation
4
Stroke-related disability assessed by the change in Barthel Index from baseline to 14th day after treatment initiation
Timeframe: From baseline to 14th day after treatment initiation
Trial details
NCT IDNCT05242393
SponsorFederal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health