Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation

NCT03135496 | Completed

• 1 other identifier: PI2016_843_0029
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is likely that a significant number of patients suffer from pre-existing endothelial dysfunction that can be evaluated by a molecular approach. To date, the replacement of the aortic valve can be performed by surgery with extracorporeal circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC. Two recent studies have demonstrated a sustained improvement in endothelial function with TAVI. On the contrary, studies have demonstrated that post-operative complications (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure) after surgery with extracorporeal circulation (CEC) could be the result of the interaction between pre-existing endothelial dysfunction And the "operative" aggression associated with the CEC. Thus, patients with preexisting involvement of endothelial function would develop vascular dysfunction after valvular replacement due to "endothelial activation" related to CEC. This phenomenon would not exist in TAVI, and would explain the absence of so-called vascular dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome, disseminated intravascular coagulation).

Conditions

Endothelial Dysfunction; Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• Analysis of the variation of the following endothelial function markers: angiopoetin 1 and 2 depending on whether or not extracorporeal circulation

  1 week

Study Arms (2)

Surgery with CEC

Other: Study of endothelial function biological markers

Without CEC

Other: Study of endothelial function biological markers

Interventions

Study of endothelial function biological markers OTHER

Study of endothelial function biological markers

Surgery with CEC; Without CEC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

(Angiopoietin 1 and 2) in two types of populations: one with CEC and one without CEC (TAVI).

You may qualify if:

• Patient ≥ 18 years.
• Patient operated on aortic valvular replacement by bioprosthesis in surgery + CEC or TAVI
• Signed consent.
• Affiliation to Social Security

You may not qualify if:

• Any other cardiac surgery
• Mechanical aortic valve replacement
• Permanent Ac / Fa.
• Pregnant woman.
• Curative anticoagulation (AVK, NANCO, heparin).
• Patient under tutelage or curatelle.
• Refusal of the patient.
• Participation in another study.
• Preoperative sepsis
• Minor or adult, under guardianship or curatorship

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 1, 2017
• Study Start: January 5, 2017
• Primary Completion: January 4, 2019
• Study Completion: January 4, 2019
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

FR (1)