IVUS Assessment of Atheroma Burden After Acute Coronary Syndrome
OPTIVUS
Intravascular Ultrasound (IVUS) Assessment of the Atherosclerotic Plaque Causing an Acute Coronary Syndrome: One-year Changes Under Optimal Secondary Prevention Drug Treatment
2 other identifiers
observational
79
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2011
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 31, 2020
July 1, 2020
8.8 years
June 30, 2011
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
atheroma volume
One-year changes in percent atheroma volume (PAV), measured in the lesion which has promoted the ACS (unstable plaque).
one year
Secondary Outcomes (4)
PAV
1 year
incidence of the clinical cardiovascular events
1 year
TAV
1 year
normalized TAV
1 year
Eligibility Criteria
female and male aged more than 18 years hospitalized for acute coronary syndrom
You may qualify if:
- adult patients hospitalized for ACS, for whom the target lesion has less than 70% stenosis and not treated with coronary angioplasty.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UH Bordeaux Haut-Lévêque
Pessac, Bordeaux Pessac, 33604, France
UH Limoges
Limoges, 87042, France
UH Toulouse
Toulouse, 31059, France
Biospecimen
bioanalysis on DNA, searching genes involving coronary disease
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Meyer Elbaz, PhD
University Hospital, Toulouse
- PRINCIPAL INVESTIGATOR
Pierre Coste, PhD
University Hospital, Bordeaux
- PRINCIPAL INVESTIGATOR
Patrice Virot, PhD
UH Limoges
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2011
First Posted
April 16, 2012
Study Start
March 1, 2011
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
July 31, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share