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Epigenome-wide DNA Methylation Profiling in Aneurysmal Subarachnoid Hemorrhage and Delayed Ischemic Neurologic Deficit

Poland61 participantsStarted 2021-12-20

Plain-language summary

The goal of this observational study is to investigate DNA methylation changes in adults with bleeding from brain aneurysm, which is called aneurysmal subarachnoid hemorrhage (aSAH), and their association with delayed ischemic neurologic deficit (DIND). The main questions it aims to answer are: Are there specific DNA methylation changes in peripheral blood that differentiate patients with aSAH from healthy individuals? Can DNA methylation changes in peripheral blood predict the development of DIND following aSAH? Researchers will compare blood DNA methylation profiles of aSAH patients to healthy controls and also do subgroup analysis of patients with DIND versus those without DIND to see if there are distinct methylation patterns associated with aSAH and DIND. Participants with aSAH will: * Have a blood sample collected shortly after admission to hospital. * Undergo epigenome-wide DNA methylation profiling using the Infinium MethylationEPIC v2.0 BeadChip microarray. * Be monitored for the development of DIND, defined by clinical symptoms and radiographic vasospasm. This study aims to identify potential epigenetic biomarkers for aSAH susceptibility and DIND risk, which could improve early diagnosis and risk stratification in affected patients.

Who can participate

Age range

18 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: * subarachnoid hemorrhage in computed tomography (CT) scan * ruptured aneurysm identified with angio-CT or digital subtraction angiography (DSA) * aneurysm successfully embolized or clipped * obtained informed consent * Hunt-Hess grade ≤ 3 by day 14 (initial higher grade was allowed providing that patient improved to grade 3 or higher by day 14) Exclusion Criteria: * \< 18 years old * unable to sign informed consent * diagnosis of idiopathic perimesencephalic subarachnoid hemorrhage * aneurysm identified more than 14 days after the ictus * more than 14 days at the Intensive Care Unit * remaining in Hunt Hess grade 5 or World Federation of Neurological Surgeons (WFNS) grade 5 from admission up to post-bleeding day 14

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

DNA methylation changes associated with aneurysmal subarachnoid hemorrhage and delayed ischemic neurologic deficit

Timeframe: Within four days following the enrollment (as blood samples will be collected within days 1-4 post-hemorrhage). Methylation profiling and CpG analysis the entire batch will be conducted within one year following enrollment of the last participant

Trial details

NCT IDNCT06881329

SponsorPomeranian Medical University Szczecin

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-12

View on ClinicalTrials.gov More Subarachnoid Hemorrhage, Aneurysmal trials