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Relationship Between Fractional Flow Reserve/ Instantaneous Wave Free Ratio and Endothelial Wall Shear Stress (RELATE)

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ClinicalTrials.gov Identifier: NCT04048005
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Politecnico di Torino
Information provided by (Responsible Party):
Fabrizio D'Ascenzo, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Brief Summary:
This study, designed as a retrospective registry, aims to investigate the relationship and potential interplay between fractional flow reserve (FFR) or instantaneous waves free ratio (iFR) with wall shear stress (WSS) in the context of intermediate coronary stenosis.

Condition or disease Intervention/treatment
Stable Angina Acute Coronary Syndrome Coronary Artery Disease Diagnostic Test: Fractional flow reserve

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: RELATionship bEtween Lesion-level Invasive Fractional Flow Reserve AND Endothelial Wall Shear Stress the RELATE FFR and WSS Study
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Diagnostic Test: Fractional flow reserve
    Other Name: instantaneous wave free ratio


Primary Outcome Measures :
  1. Wall shear stress (WSS) / Fractional flow reserve (FFR) or instantaneous wave free ratio (iFR)correlation [ Time Frame: WSS will be calculated after 3D coronary reconstruction, within one year after the completion of retrospective enrollement ]
    After 3-dimensional coronary reconstruction through dedicated software (Qangio XA 3D (MEDIS), WSS will be calculated through fluydodinamic equations across the entire coronary vessel and across coronary stenosis. WSS values predicting positive invasive FFR and iFR (according to their dichothomic established values of positivity, namely FFR < 0.8 and iFR < 0.89) measurements will be searched, along with any possible relationship between WSS and FFR/iFR as continuos values.

  2. MACE (major adverse cardiovascular events) [ Time Frame: MACE will be evaluated for each patients through study completion, an average of 1 year ]
    The association of regional WSS with major cardiovascular adverse events at available follow-up will be further evaluated to assess if lesion-level WSS might predict overall patient-level outcomes



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
- The study will include any patient referred for coronary angiography at each involved center and with a subsequent invasive physiological assessment performed with FFR or iFR (or both) at operating physician's discretion on intermediate coronary stenosis (diameter of stenosis ranging from 30-90% at visual angiographic estimation).
Criteria

Inclusion Criteria:

  • Angiography performed for suspected symptom/ischemia-driven stable coronary artery disease or for acute coronary syndromes
  • At least one lesion with 30-90% diameter stenosis at invasive angiography with FFR/iFR assessed (for patients with acute coronary syndromes, the invasive assessment will be performed on non-culprit stenosis
  • Patient informed consent for data collection and publication in anonymous studies

Exclusion Criteria:

  • Quality of angiographic frames not sufficient for 3D-reconstruction and/or computations
  • Patients denying informed consent

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): NCT04048005


Locations
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Italy
Ospedale di Rivoli Enrolling by invitation
Rivoli, Italy, 10098
AOU Città della Salute e della Scienza di Torino Recruiting
Torino, Italy, 10126
Contact: Fabrizio D'Ascenzo, MD    +390116336023    fabrizio.dascenzo@gmail.com   
Ospedale San Giovanni Bosco Enrolling by invitation
Torino, Italy, 10144
Sponsors and Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Politecnico di Torino

Publications:

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Responsible Party: Fabrizio D'Ascenzo, Medical Doctor, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT04048005     History of Changes
Other Study ID Numbers: RELATE FFR and WSS
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Chest Pain
Pain
Coronary Artery Disease
Acute Coronary Syndrome
Angina, Stable
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Neurologic Manifestations
Signs and Symptoms