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

NCT04557345 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2020-09-21

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Determination of cytokines

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.

DIAGNOSTIC_TEST

Two-dimensional transthoracic echocardiogram

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.

Sponsors & Collaborators

  • Instituto Nacional de Cardiologia Ignacio Chavez

    lead OTHER

Principal Investigators

  • Maria Elena Soto Lopez, PhD · Instituto Nacional de Cardiologia Ignacio Chavez

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1990-01-01
Primary Completion
2020-08-01
Completion
2020-08-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04557345 on ClinicalTrials.gov