Biological Factors Associated With Subclinical Valvular Thrombosis (START)

October 28, 2021 updated by: Pilar Jimenez Quevedo, Hospital San Carlos, Madrid

Evaluation of Biological Factors Associated With Subclinical Valvular Thrombosis in pAtients With Severe aoRtic Stenosis Undergoing TAVI: START Trial

A prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI).

- The main objective is to determine whether the high residual platelet reactivity rates in patients undergoing TAVI is associated with the occurrence of clinical and / or subclinical prosthetic valve thrombosis measured by echocardiography and multi-slice computerized tomography

Study Overview

Status

Recruiting

Conditions

Detailed Description

For the purpose of the study, platelet reactivity will be measured with the commercial kit PLT VASP/P2Y12 at baseline, 1day and 3 months postprocedure.

Secondary objectives include: -Determine the variability of platelet aggregation measured at baseline before the procedure, 1-day post-procedure and at 3-6 and 1 year follow-up.

  • To determine whether the pro-thrombotic inflammatory response measured by the CD14 + and CD16 + quantification observed after TAVI is associated with the appearance of prosthetic thrombosis.
  • To evaluate the Correlation of Von Willebrand factor levels and distribution of Von Willebrand multimers with the appearance of prosthetic thrombosis at baseline before the procedure, 1-day post-procedure and at 3, 6 months follow-up and 1 year.
  • To determine whether the residual platelet reactivity rates in patients undergoing TAVI are associated with the occurrence of clinical events, at baseline before the procedure, 1-day post-procedure and at 3,6 months follow-up and 1 year
  • To evaluate the clinical factors associated with the appearance of early prosthetic thrombosis.

Study Type

Observational

Enrollment (Anticipated)

166

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clínico San Carlos
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pilar Jimenez Quevedo, MD, PhD
        • Principal Investigator:
          • maria del Trigo, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with severe symptomatic aortic stenosis treated with TAVI

Description

Inclusion Criteria:

  • Patients with severe symptomatic aortic stenosis who it was accepted to be treated with TAVI by a multidisciplinary team "Heat Team".
  • TAVI was successfully implanted (according to Valve Academic Research Consortium II criteria) and are under treatment with double antiplatelet therapy.
  • Signed informed consent to participate in this study.

Exclusion Criteria:

  • Age under 18 years and pregnant or of childbearing age.
  • Acute Recent stroke recent <14 days before TAVI.
  • The patients with proven allergy to aspirin, clopidogrel
  • Patients that after TAVI cannot undergo a double antiplatelet regimen for 6 months due to a new post-TAVI medical indication or are anticoagulated.
  • Knowledge of pregnancy or lactation Thrombocytopenia (<50,000 platelets U / L) well documented and clinically relevant.
  • The patients with documented moderate or severe hepatic insufficiency
  • Severe chronic renal insufficiency with creatinine clearance <30 ml / min.
  • The patients who can not attend the follow-up visits scheduled in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association between high residual platelet reactivity rates in patients undergoing TAVI with the occurrence of clinical and / or subclinical prosthetic valve thrombosis
Time Frame: at 3 months
platelet reactivity will be measured with the commercial kit platelet Vasodilator Stimulated Phosphoprotein (VASP)/P2Y12 and subclinical valve thrombosis by transthoracic echocardiography and multi-slice computerized tomography
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the variability of platelet aggregation
Time Frame: at baseline, 1 day post-procedure and at 3-6 months and 1 year follow-up.
platelet aggregation
at baseline, 1 day post-procedure and at 3-6 months and 1 year follow-up.
To quantify the pro-thrombotic inflammatory response
Time Frame: at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
measured by serum levels of (cluster of differentiation 14) CD14 + and (cluster of differentiation 16) CD16 +
at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
To correlate of Von Willebrand factor levels and distribution of Von Willebrand factor multimers with the appearance of prosthetic thrombosis
Time Frame: at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
Serum Von Willebrand factor levels and distribution of Von Willebrand factor multimers with the appearance of prosthetic thrombosis assessed by transthoracic echocardiography or multi-slice computerized tomography
at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
To correlate residual platelet reactivity with clinical events
Time Frame: at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
platelet aggregation
at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.
To evaluate clinical factors associated with the appearance of early prosthetic thrombosis.
Time Frame: multi slice computerized tomography at 3 month and clinical up to 1 year.
to perform Multislice computerized tomography and clinical follow-up
multi slice computerized tomography at 3 month and clinical up to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

March 31, 2022

Study Registration Dates

First Submitted

February 3, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (ACTUAL)

February 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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