NCT02972008Recruiting
Identification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 542 (estimated)
- First submitted
- 21 Nov 2016
- Start date
- 9 Mar 2017
- Primary completion date
- Feb 2027
- Lead sponsor
- University Hospital, Lille
- Diseases
- Stroke
- NCT number
- NCT02972008
What you commit to
- Study type: Observational
- Planned participants: 542
- From 9 Mar 2017 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Ongoing cancer
Other
- 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.
Who the study is looking for
- Patients over 70 years with severe aortic stenosis requiring percutaneous aortic valve replacement (TAVI)
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital cardiologie, CHRU Coordinator of this site? Confirm its status | Lille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.