IVUS Assessment of Atheroma Burden After Acute Coronary Syndrome (OPTIVUS)
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Toulouse
Sponsor:
University Hospital, Toulouse
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01578005
First received: June 30, 2011
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
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 |
|---|
|
Acute Coronary Syndrome |
| Study Type: | Observational |
| Study Design: | 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 |
Further study details as provided by University Hospital, Toulouse:
Primary Outcome Measures:
- atheroma volume [ Time Frame: one year ] [ Designated as safety issue: Yes ]One-year changes in percent atheroma volume (PAV), total atheroma volume (TAV) and normalized TAV, measured in the lesion which has promoted the ACS (unstable plaque).
Secondary Outcome Measures:
- PAV [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]one year incidence of clinical cardiovascular events (death, acute coronary syndrome, ischaemic stroke, revascularization, hospitalization for heart failure).
- TAV [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]One-year changes in PAV, TAV and normalized TAV, in a stable plaque (not involved in the ACS)
- normalized TAV [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578005
Contacts
| Contact: Meyer ELBAZ, PhD | 05 61 32 3316 ext +33 | elbaz.m@chu-toulouse.fr |
Locations
| 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
| Study Chair: | Meyer Elbaz, PhD | University Hospital, Toulouse |
| Principal Investigator: | Pierre Coste, PhD | UH Bordeaux |
| Principal Investigator: | Patrice Virot, PhD | UH Limoges |
More Information
No publications provided
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT01578005 History of Changes |
| Other Study ID Numbers: | 1004708, 2010-A00471-38 |
| Study First Received: | June 30, 2011 |
| Last Updated: | January 22, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Toulouse:
|
acute coronary syndrome IVUS atherosclerotic plaque |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Plaque, Atherosclerotic Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013