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Identification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• Patients over 70 years with severe aortic stenosis requiring percutaneous aortic valve replacement (TAVI)

Locations
Other Locations
France
Hôpital cardiologie, CHRU
RECRUITING
Lille
Contact Information
Primary
Nicolas Debry, MD
nicolas.debry@chru-lille.fr
+33 3 20 44 59 62
Time Frame
Start Date: 2017-03-09
Estimated Completion Date: 2026-02
Participants
Target number of participants: 542
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov