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Biological Factors Associated With Subclinical Valvular Thrombosis (START)

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ClinicalTrials.gov Identifier: NCT03847948
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborators:
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Instituto Carlos III
Information provided by (Responsible Party):
Pilar Jimenez Quevedo, Hospital San Carlos, Madrid

Brief Summary:

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


Condition or disease
Aortic Stenosis

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 166 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Evaluation of Biological Factors Associated With Subclinical Valvular Thrombosis in pAtients With Severe aoRtic Stenosis Undergoing TAVI: START Trial
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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 +

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with severe symptomatic aortic stenosis treated with TAVI
Criteria

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

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): NCT03847948


Locations
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Spain
Hospital Clinic Not yet recruiting
Barcelona, Spain
Contact: Ander Regueiro, MD, PhD       anderregueiro@gmail.com   
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Pilar Jimenez Quevedo, MD, PhD    34-9-1330-3283    patrop@telefonica.net   
Contact: Esther Bernado, Drs       ebernardogarcia@yahoo.es   
Principal Investigator: Pilar Jimenez Quevedo, MD, PhD         
Principal Investigator: maria del Trigo, MD, PhD         
Sponsors and Collaborators
Hospital San Carlos, Madrid
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Instituto Carlos III

Additional Information:

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Responsible Party: Pilar Jimenez Quevedo, MD, PhD, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03847948     History of Changes
Other Study ID Numbers: PI17/01685
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Constriction, Pathologic
Thrombosis
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction