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OPTIVUS: IVUS Assessment of Atheroma Burden After Acute Coronary Syndrome

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT01578005
Collaborator
(none)
79
Enrollment
3
Locations
105
Actual Duration (Months)
26.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Coronary angioplasty is rather frequently performed in such situations, presumably because, changes in the atherosclerotic plaque under drug treatment, have remained poorly described so far. Intravascular ultrasound (IVUS) enables a precise description of coronary atheroma, better than the one provided by coronary angiography.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    According to current guidelines, patients with coronary lesions with stenosis <70% should receive optimal secondary prevention drug treatment without angioplasty, even after an acute coronary syndrome (ACS). Nevertheless, coronary angioplasty is rather frequently performed in such situations, presumably because, changes in the atherosclerotic plaque under drug treatment, have remained poorly described so far. Intravascular ultrasound (IVUS) enables a precise description of coronary atheroma, better than the one provided by coronary angiography.

    The first objective is to assess by endo-coronary ultrasound, under optimal medical treatment, the evolution of atheromatous plaque (with stenosis <70%). The evolution will be appreciated after 12 months of treatment the percentage of atheromatous volume (PVA). The aim of the first secondary objective to evaluate, after 12 months of treatment, the evolution of the total atheromatous volume (VAT) and the standardized total atheromatous volume (standardized VAT). The Second secondary objective is to evaluate by endo-coronary ultrasound, the evolution of a stable atheromatous plaque. This analysis will be performed in patients with a second coronary lesion (atheroma plaque), resulting in less than 70% stenosis, and not being responsible for acute coronary syndrome. The evolution of the stable plate will be compared to the evolution of the unstable plate. Finally, the third secondary objective is to estimate the incidence of clinical events (death, acute coronary syndromes, ischemic stroke, revascularization, hospitalization for heart failure) within 12 months of the occurrence of an acute coronary syndrome managed by medical treatment optimal secondary prevention (without performing angioplasty).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    79 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Intravascular Ultrasound (IVUS) Assessment of the Atherosclerotic Plaque Causing an Acute Coronary Syndrome: One-year Changes Under Optimal Secondary Prevention Drug Treatment
    Actual Study Start Date :
    Mar 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2019
    Actual Study Completion Date :
    Dec 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. atheroma volume [one year]

      One-year changes in percent atheroma volume (PAV), measured in the lesion which has promoted the ACS (unstable plaque).

    Secondary Outcome Measures

    1. PAV [1 year]

      One-year changes total atheroma volume (TAV) and normalized TAV. One year changes in PAV, TAV and normalized TAV in a stable plaque (not involved in the ACS).

    2. incidence of the clinical cardiovascular events [1 year]

      one year incidence of clinical cardiovascular events (death, acute coronary syndrome, ischaemic stroke, revascularization, hospitalization for heart failure).

    3. TAV [1 year]

      One-year changes in PAV, TAV and normalized TAV, in a stable plaque (not involved in the ACS)

    4. normalized TAV [1 year]

      One-year changes in PAV, TAV and normalized TAV, in a stable plaque (not involved in the ACS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • adult patients hospitalized for ACS, for whom the target lesion has less than 70% stenosis and not treated with coronary angioplasty.
    Exclusion Criteria:
    • Patients presenting with a target lesion with ≥70% stenosis ; Patients for whom the target lesion is treated with coronary angioplasty ; Interventions: A first IVUS will be performed after the acute coronary event (baseline) and will be done again one-year after to assess changes in the atherosclerotic plaques.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UH Bordeaux Haut-Lévêque Pessac Bordeaux Pessac France 33604
    2 UH Limoges Limoges France 87042
    3 UH Toulouse Toulouse France 31059

    Sponsors and Collaborators

    • University Hospital, Toulouse

    Investigators

    • Study Chair: Meyer Elbaz, PhD, University Hospital, Toulouse
    • Principal Investigator: Pierre Coste, PhD, UH Bordeaux
    • Principal Investigator: Patrice Virot, PhD, UH Limoges

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Toulouse
    ClinicalTrials.gov Identifier:
    NCT01578005
    Other Study ID Numbers:
    • RC31/10/047
    • 2010-A00471-38
    First Posted:
    Apr 16, 2012
    Last Update Posted:
    Jul 31, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Toulouse
    acute coronary syndrome
    IVUS
    atherosclerotic plaque
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome

    Study Results

    No Results Posted as of Jul 31, 2020