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
|Condition or disease|
|Acute Coronary Syndrome|
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 Type :||Observational|
|Estimated Enrollment :||82 participants|
|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|
- 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).
- 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).
- 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).
- TAV [ Time Frame: 1 year ]One-year changes in PAV, TAV and normalized TAV, in a stable plaque (not involved in the ACS)
- 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
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
|Contact: Meyer ELBAZ, PhD||05 61 32 3316 ext +email@example.com|
|UH Bordeaux Haut-Lévêque||Not yet recruiting|
|Pessac, Bordeaux Pessac, France, 33604|
|Contact: Pierre Coste, PhD 05.57.65.64.57 firstname.lastname@example.org|
|Principal Investigator: Pierre Coste, PhD|
|UH Limoges||Not yet recruiting|
|Limoges, France, 87042|
|Contact: Patrice Virot, PhD 05.55.05.63.10 email@example.com|
|Principal Investigator: Patrice Virot, PhD|
|Toulouse, France, 31059|
|Contact: Meyer Elbaz, PhD 05 61 32 33 16 ext +33 firstname.lastname@example.org|
|Principal Investigator: Meyer Elbaz, PhD|
|Study Chair:||Meyer Elbaz, PhD||University Hospital, Toulouse|
|Principal Investigator:||Pierre Coste, PhD||UH Bordeaux|
|Principal Investigator:||Patrice Virot, PhD||UH Limoges|