Epigenetic risk factors for silent brain injury after TAVR in older adults
Official title: Identification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly
Run by University Hospital, Lille · NCT02972008 · Data updated 2026-11-12
This project will test whether blood epigenetic markers can predict new silent stroke-like brain lesions and later memory decline in people over 70 having TAVR.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 70 Years and up |
| Sex | All |
| Enrollment | 542 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | March 9, 2017 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT02972008 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 70 or older with severe symptomatic aortic stenosis who are scheduled for percutaneous aortic valve replacement (TAVR), can undergo brain MRI, and can give informed consent.
✕Probably not a fit
Patients who cannot have MRI (for example those with pacemakers), those with ongoing cancer, those already enrolled in other therapeutic research, or those legally unable to consent are unlikely to benefit from participation in this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a French multicenter prospective cohort enrolling patients over 70 with severe symptomatic aortic stenosis who are scheduled for TAVR at participating university hospitals. Clinical data and cognitive testing with the mini-mental state exam are collected before the procedure and again at one year, and brain MRI is performed within 1–3 days after TAVR to detect new ischemic lesions. Blood samples are taken before, during, and on days 1 and 4 after the procedure to analyze epigenetic markers. The study links imaging, cognitive outcomes, and blood-based epigenetic profiles to see if specific markers are associated with periprocedural ischemic injury and later cognitive decline.
Why it matters
Potential benefit: If successful, clinicians could use a blood-based epigenetic test to identify patients at higher risk of silent brain injury after TAVR and target monitoring or prevention to reduce cognitive decline.
How similar studies have gone: Previous MRI studies have consistently shown high rates of silent ischemic lesions after TAVR, but using blood epigenetic markers to predict those events is a novel approach with limited prior evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 70 years with severe aortic stenosis requiring percutaneous aortic valve replacement (TAVI) Exclusion Criteria: * Patient contraindicated for the TAVI procedure * Patient with a pace-maker * Patient with contra-indication for cerebral MRI * Ongoing cancer * Patient already involved in therapeutic research * Major persons under protection of justice.
Where it's running
-
Hôpital cardiologie, CHRU
Lille, France Recruiting
Study contacts
- Principal investigator: Nicolas Debry, MD — University Hospital, Lille
- Study coordinator: Nicolas Debry, MD
- Email: nicolas.debry@chru-lille.fr
- Phone: +33 3 20 44 59 62
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.