NCT02972008 Identification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly
| NCT ID | NCT02972008 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Cognitive Decline |
| Study Type | OBSERVATIONAL |
| Enrollment | 542 participants |
| Start Date | 2017-03-09 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 542 participants in total. It began in 2017-03-09 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Nicolas Debry, MD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT02972008 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Cognitive Decline. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02972008 currently recruiting?
Yes, NCT02972008 is actively recruiting participants. Contact the research team at nicolas.debry@chru-lille.fr for enrollment information.
Where is the NCT02972008 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT02972008 clinical trial?
NCT02972008 is sponsored by University Hospital, Lille. The principal investigator is Nicolas Debry, MD at University Hospital, Lille. The trial plans to enroll 542 participants.