Acute Coronary SyndromeOPTIVUSNCT01578005
IVUS Assessment of Atheroma Burden After Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by University Hospital, Toulouse at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 79 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2011to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: female and male aged more than 18 years hospitalized for acute coronary syndrom
Who may be able to join
- adult patients hospitalized for ACS, for whom the target lesion has less than 70% stenosis and not treated with coronary angioplasty.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
UH Limoges
Limoges, 87042
UH Bordeaux Haut-Lévêque
Pessac, Bordeaux Pessac, 33604
UH Toulouse
Toulouse, 31059
About this study
Official title: Intravascular Ultrasound (IVUS) Assessment of the Atherosclerotic Plaque Causing an Acute Coronary Syndrome: One-year Changes Under Optimal Secondary Prevention Drug Treatment
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.
Read the 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).
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, IVUS, atherosclerotic plaque
- Medical subject headings
- Acute Coronary Syndrome, Plaque, Atherosclerotic
What is being measured
The primary outcome is the main question the study is designed to answer.
atheroma volume
One-year changes in percent atheroma volume (PAV), measured in the lesion which has promoted the ACS (unstable plaque).
Measured: one year
Secondary outcomes (4)
PAV
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).
Measured: 1 year
incidence of the clinical cardiovascular events
one year incidence of clinical cardiovascular events (death, acute coronary syndrome, ischaemic stroke, revascularization, hospitalization for heart failure).
Measured: 1 year
TAV
One-year changes in PAV, TAV and normalized TAV, in a stable plaque (not involved in the ACS)
Measured: 1 year
normalized TAV
One-year changes in PAV, TAV and normalized TAV, in a stable plaque (not involved in the ACS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meyer Elbaz, PhD, Study chair, University Hospital, ToulousePierre Coste, PhD, Principal investigator, University Hospital, BordeauxPatrice Virot, PhD, Principal investigator, UH Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578005
- Sponsor's protocol ID
- RC31/10/047
- Other IDs
- 2010-A00471-38
- Acronym
- OPTIVUS
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2011
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound (IVUS) Assessment of the Atherosclerotic Plaque Causing an Acute Coronary Syndrome: One-year Changes Under Optimal Secondary Prevention Drug Treatment
- ClinicalTrials.gov ID
- NCT01578005
- Acronym / sponsor ID
- OPTIVUS / RC31/10/047
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, IVUS, atherosclerotic plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female and male aged more than 18 years hospitalized for acute coronary syndrom
Key inclusion criteria (1 listed)
- adult patients hospitalized for ACS, for whom the target lesion has less than 70% stenosis and not treated with coronary angioplasty.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
PAV
Time frame: 1 year
incidence of the clinical cardiovascular events
Time frame: 1 year
TAV
Time frame: 1 year
normalized TAV
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meyer Elbaz, PhD study chair
University Hospital, Toulouse
Pierre Coste, PhD principal investigator
University Hospital, Bordeaux
Patrice Virot, PhD principal investigator
UH Limoges
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by University Hospital, Toulouse at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atheroma volume (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.