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IVUS Assessment of Atheroma Burden After Acute Coronary Syndrome (OPTIVUS)

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ClinicalTrials.gov Identifier: NCT01578005
Recruitment Status : Recruiting
First Posted : April 16, 2012
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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
Acute Coronary Syndrome

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).


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Study Type : Observational
Estimated Enrollment : 82 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
Study Start Date : March 2011
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020



Primary Outcome Measures :
  1. atheroma volume [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]
    one year incidence of clinical cardiovascular events (death, acute coronary syndrome, ischaemic stroke, revascularization, hospitalization for heart failure).

  3. TAV [ Time Frame: 1 year ]
    One-year changes in PAV, TAV and normalized TAV, in a stable plaque (not involved in the ACS)

  4. normalized TAV [ Time Frame: 1 year ]
    One-year changes in PAV, TAV and normalized TAV, in a stable plaque (not involved in the ACS)


Biospecimen Retention:   Samples With DNA
bioanalysis on DNA, searching genes involving coronary disease


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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
female and male aged more than 18 years hospitalized for acute coronary syndrom
Criteria

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.

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): NCT01578005


Contacts
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Contact: Meyer ELBAZ, PhD 05 61 32 3316 ext +33 elbaz.m@chu-toulouse.fr

Locations
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France
UH Bordeaux Haut-Lévêque Not yet recruiting
Pessac, Bordeaux Pessac, France, 33604
Contact: Pierre Coste, PhD    05.57.65.64.57    pierre.coste@u-bordeaux2.fr   
Principal Investigator: Pierre Coste, PhD         
UH Limoges Not yet recruiting
Limoges, France, 87042
Contact: Patrice Virot, PhD    05.55.05.63.10    patrice.virot@chu-limoges.fr   
Principal Investigator: Patrice Virot, PhD         
UH Toulouse Recruiting
Toulouse, France, 31059
Contact: Meyer Elbaz, PhD    05 61 32 33 16 ext +33    elbaz.m@chu-toulouse.fr   
Principal Investigator: Meyer Elbaz, PhD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Study Chair: Meyer Elbaz, PhD University Hospital, Toulouse
Principal Investigator: Pierre Coste, PhD UH Bordeaux
Principal Investigator: Patrice Virot, PhD UH Limoges

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01578005     History of Changes
Other Study ID Numbers: RC31/10/047
2010-A00471-38 ( Other Identifier: ANSM )
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 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
Keywords provided by University Hospital, Toulouse:
acute coronary syndrome
IVUS
atherosclerotic plaque
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases