Studies DNA changes linked to brain injury after heart valve procedure in older adults
Observes whether DNA changes predict brain injury in older adults undergoing aortic valve replacement.
Key facts
- Who runs it
- University Hospital, Lille
- Where
- Lille, FranceSee the site
- Trial code
- Registry title
- Identification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly
- Status
- Recruiting
- People taking part
- 542 people, planned
- Started
- 9 Mar 2017
- Expected to end
- Feb 2027
- Type of study
- Observational, 3 groups
- Record updated
- 22 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people over 70 with severe aortic stenosis who need a percutaneous aortic valve replacement (TAVI). It studies whether a DNA change in white blood cells predicts new brain lesions after the procedure.
- Age
- Over 70 years
- Sex
- All sexes can join.
- Disease stage
- Severe aortic stenosis that needs a percutaneous aortic valve replacement (TAVI).
Main reasons for not taking part
- Cannot have the TAVI procedure
- Has a pace-maker
- Cannot have a brain MRI scan
- Has ongoing cancer
- Already takes part in therapeutic research
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Patients over 70 years with severe aortic stenosis requiring percutaneous aortic valve replacement (TAVI)
Who cannot take part
- Ongoing cancer
- Patient contraindicated for the TAVI procedure
- Patient with a pace-maker
- Patient with contra-indication for cerebral MRI
- Patient already involved in therapeutic research
- Major persons under protection of justice
Where in France
- Hôpital cardiologie, CHRULille, FranceContact: Nicolas Debry, MD (principal investigator)Taking people
About the trial
What the trial wants to find out
Over the past ten years, the number of endovascular procedures has increased by 5% per year in Europe with the development of interventional cardiology, such as percutaneous coronary angioplasty, aortic valve replacements (TAVR), and vascular endoprosthesis.
Read full original descriptionShow less
The neurological lesions detected on cerebral MRI caused by these endovascular procedures are frequent with an incidence of about 30-70%. These events, although subclinical, have an impact on morbidity and mortality and especially on long-term cognitive decline.
TAVR is the reference treatment for symptomatic elderly patients with stenosis of the aortic valve, considered by a multidisciplinary "Heart Team" as at high surgical risk due to comorbidities, age and high perioperative risk scores ( Euroscore 2 and STS scores). Despite the net clinical benefit, an increase of silent neurological events was detected on post-procedural cerebral MRI with an incidence of approximately 70%.
The epigenetic involvement in the occurrence of ischemic cerebral lesions is still largely unknown. Epigenetic mechanisms, such as DNA methylation, can be associated with aging processes and modulate the risk of developing cerebrovascular pathologies. They are likely to provide new biomarkers that predict the risk of brain damage.
Hypomethylation of leukocyte DNA is directly related to atherosclerosis in humans. This hypomethylation of DNA would represent an easily measurable marker reflecting the presence and progression of atherosclerosis. Because atherosclerotic lesions often precede the clinical manifestation of ischemic cardiovascular disease, such as ischemic heart disease and stroke, DNA hypomethylation could be used to identify individuals at risk for cerebrovascular events.
The investigator hypothesize that hypomethylation of leukocyte DNA can predict the risk of developing new ischemic brain lesions especially after a TAVI procedure.
The 3 groups in the trial
- Cerebral Lesion
Patient over 70 years with severe aortic stenosis requiring percutaneous aortic valvular replacement (TAVI) having at least one new cerebral ischemic lesion on postoperative cerebral MRI
- No Cerebral Lesion
Patient over 70 years with severe aortic stenosis requiring percutaneous aortic valvular replacement (TAVI) with no cerebral ischemic lesion on postoperative cerebral MRI
- patients with constitutional von Willebrand factor (vWF) deficiency
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Identification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly
- Plain-language title
- Studies DNA changes linked to brain injury after heart valve procedure in older adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 22 May 2026