IVUS Assessment of Atheroma Burden After Acute Coronary Syndrome (OPTIVUS)

This study is currently recruiting participants.
Verified December 2013 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01578005
First received: June 30, 2011
Last updated: December 18, 2013
Last verified: December 2013
  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)
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.

  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: December 18, 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 April 17, 2014