Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.

NCT04557345 | Completed

• 1 other identifier: 17-1033
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America. Previous evidence shows that aortic valve calcification is an active biological process associated with inflammation. The only actual treatment for severe aortic stenosis is surgical aortic valve replacement (AVR). The materials with which the different types of prostheses are manufactured could induce inflammation per se. Biological prostheses, an incomplete cell removal process and therefore, the presence of residual proteins of animal origin, could induce the immune system's response. In the manufacturing bioprosthesis at the "Ignacio Chávez" National Institute of Cardiology (INC), an evaluation was carried out in the early, and late post-surgical period, it was shown that the inflammatory response after six months is similar to that produced by mechanical prosthesis. This study's main objective is to evaluate the inflammatory response in patients with post-operated AVR due to biological or mechanical prosthetic valve through different plasma biomarkers in long-term follow-up. Research question What is the inflammatory response and calcification in patients who undergo aortic valve replacement for a manufactured prosthesis at the "Ignacio Chávez" National Institute of Cardiology in the long-term follow-up? Hypothesis Manufactured bioprostheses at the "Ignacio Chávez" National Institute of Cardiology show a similar or lower inflammatory response to imported bioprostheses or mechanical prostheses associated with less valve dysfunction and more outstanding durability.

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Calcification; Prosthetic Valve Malfunction

Outcome Measures

Primary Outcomes (1)

• Quantify the long-term inflammatory response of INC bioprostheses implanted in the aortic position.

  Serum measurements of RANK, RANKL, IL-10 (pg/cc), IL-1 (pg/cc), IL-6(pg/cc), ICAM-1 (pg/cc), MMP-9, endothelin-1, osteopontin, osteprogesterin, and TNF-alpha (pg/cc) will be performed.

  An average of 6 years

Secondary Outcomes (2)

• Compare the long-term inflammatory response of INC bioprostheses implanted in the aortic position to imported bioprostheses and mechanical prostheses.

  An average of 6 months

• The inflammatory response of post-bioprosthesis operated patients will be compared with a control group.

  Through study completion, an average of 6 years

Study Arms (4)

Biological prostheses INC

Prosthetic valve manufactured in the National Institute of Cardiology "Ignacio Chávez".

Diagnostic Test: Determination of cytokines; Diagnostic Test: Two-dimensional transthoracic echocardiogram

Imported Biological aortic prostheses

St Jude EPIC and Carpentier-Edwards Perimount

Diagnostic Test: Determination of cytokines; Diagnostic Test: Two-dimensional transthoracic echocardiogram

Mechanical prostheses

St Jude Masters HP, Carbomedics Standart, ON-X Life Technologies, Edwards Mira, Carbomedics Orbis, Medtronic Hall and Medtronic ATS.

Diagnostic Test: Determination of cytokines; Diagnostic Test: Two-dimensional transthoracic echocardiogram

Control

In subjects who come to donate blood products altruistically, in the blood bank service of the INC, with prior informed consent, the subjects will be matched with PO patients of CVA by age and gender.

Diagnostic Test: Determination of cytokines; Diagnostic Test: Two-dimensional transthoracic echocardiogram

Interventions

Determination of cytokines DIAGNOSTIC_TEST

Subsequently, a blood sample will be taken from which the processing will be as follows: 6 ml of peripheral blood will be taken in tubes with a yellow cap and inert gel and clot retractor, immediately afterward it will be placed on ice, it will be transported to the laboratory where it will be centrifuged at 2500 rpm for 15 minutes at 4 degrees centigrade, immediately afterward 500 µl of serum will be aliquoted and stored at minus 75 ° C until later analysis. The general methodology for sandwich ELISA will be used.

Biological prostheses INC; Control; Imported Biological aortic prostheses; Mechanical prostheses

Two-dimensional transthoracic echocardiogram DIAGNOSTIC_TEST

With prior informed consent, a two-dimensional transthoracic echocardiogram will be obtained by an echocardiographer certified by the Mexican Council of Cardiology (CMC) with a Phillips EPIC 7 echocardiography, 2D Arrary 3D Convex (1-6 Mhz) transducer.

Biological prostheses INC; Control; Imported Biological aortic prostheses; Mechanical prostheses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have had a biological prosthetic valve implanted in aortic position manufactured at the National Institute of Cardiology "Ignacio Chávez" with an anti-calcifying system, imported biological prosthetic aortic valve or mechanical aortic valve from January 1990 to May 2020.

You may qualify if:

• Patients over 18 years of age underwent an aortic valve exchange for an INC bioprosthesis, imported bioprosthesis, or mechanical prosthesis.
• Patients with follow-up two-dimensional transthoracic echocardiography.
• Patients who agree to take a blood sample for an inflammatory profile.

You may not qualify if:

• Patients in whom more than one cardiac prosthesis was implanted in any valve position.
• Inflammatory and connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome).
• Patients undergoing aortic valve replacement due to prosthetic valve dysfunction.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional Ignacio Chavez

Mexico City, 14080, Mexico

Location

Related Publications (24)

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MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve, Calcification of

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Maria Elena Soto Lopez, PhD

  Instituto Nacional de Cardiologia Ignacio Chavez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 21, 2020
• Study Start: January 1, 1990
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

ME (1)