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IVUS Assessment of Atheroma Burden After Acute Coronary Syndrome

Intravascular Ultrasound (IVUS) Assessment of the Atherosclerotic Plaque Causing an Acute Coronary Syndrome: One-year Changes Under Optimal Secondary Prevention Drug Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01578005
Acronym
OPTIVUS
Enrollment
79
Registered
2012-04-16
Start date
2011-03-31
Completion date
2019-12-31
Last updated
2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome, IVUS, atherosclerotic plaque

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.

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).

Interventions

None listed

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
PAV1 yearOne-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).
incidence of the clinical cardiovascular events1 yearone year incidence of clinical cardiovascular events (death, acute coronary syndrome, ischaemic stroke, revascularization, hospitalization for heart failure).
TAV1 yearOne-year changes in PAV, TAV and normalized TAV, in a stable plaque (not involved in the ACS)
normalized TAV1 yearOne-year changes in PAV, TAV and normalized TAV, in a stable plaque (not involved in the ACS)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026