Informations générales (source: ClinicalTrials.gov)
Identification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly (METHYSTROKE)
Observational
University Hospital, Lille (Voir sur ClinicalTrials)
mars 2017
février 2024
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital cardiologie, CHRU - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Patients over 70 years with severe aortic stenosis requiring percutaneous aortic
valve replacement (TAVI)
- Patients over 70 years with severe aortic stenosis requiring percutaneous aortic
valve replacement (TAVI)
- 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.