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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04557345
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Elena Soto, MsC and PhD, Instituto Nacional de Cardiologia Ignacio Chavez

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.


Condition or disease Intervention/treatment
Aortic Valve Disease Aortic Valve Stenosis Aortic Valve Calcification Prosthetic Valve Malfunction Diagnostic Test: Determination of cytokines Diagnostic Test: Two-dimensional transthoracic echocardiogram

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Evaluation of the Inflammatory Response and Long-term Calcification in Post-operated Aortic Valve Replacement Patients.
Actual Study Start Date : January 1, 1990
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Biological prostheses INC
Prosthetic valve manufactured in the National Institute of Cardiology "Ignacio Chávez".
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.

Imported Biological aortic prostheses
St Jude EPIC and Carpentier-Edwards Perimount
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.

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
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.

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
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.




Primary Outcome Measures :
  1. Quantify the long-term inflammatory response of INC bioprostheses implanted in the aortic position. [ Time Frame: An average of 6 years ]
    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.


Secondary Outcome Measures :
  1. Compare the long-term inflammatory response of INC bioprostheses implanted in the aortic position to imported bioprostheses and mechanical prostheses. [ Time Frame: An average of 6 months ]
    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.

  2. The inflammatory response of post-bioprosthesis operated patients will be compared with a control group. [ Time Frame: Through study completion, an average of 6 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557345


Locations
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Mexico
Instituto Nacional Ignacio Chavez
Ciudad de mexico, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Investigators
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Principal Investigator: Maria Elena Soto Lopez, PhD Instituto Nacional de Cardiologia Ignacio Chavez
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Elena Soto, MsC and PhD, Principal Investigator, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT04557345    
Other Study ID Numbers: 17-1033
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction