Aortic Valve Stenosis Clinical Trial
Official title:
Evaluation of the Inflammatory Response and Long-term Calcification in Post-operated Aortic Valve Replacement Patients.
NCT number | NCT04557345 |
Other study ID # | 17-1033 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 1990 |
Est. completion date | August 1, 2020 |
Verified date | September 2020 |
Source | Instituto Nacional de Cardiologia Ignacio Chavez |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 1, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional Ignacio Chavez | Ciudad de mexico |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cardiologia Ignacio Chavez |
Mexico,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Compare the long-term inflammatory response of INC bioprostheses implanted in the aortic position to imported bioprostheses and mechanical prostheses. | 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 months | |
Secondary | The inflammatory response of post-bioprosthesis operated patients will be compared with a control group. | 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. | Through study completion, an average of 6 years |
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