Angioplasty of Left Main - lAriboisiere Registry (ALMA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Jean-Guillaume DILLINGER, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT01725373
First received: November 8, 2012
Last updated: January 12, 2014
Last verified: January 2014
  Purpose

In patients with unprotected left main disease (ULMD), angioplasty is emerging as an alternative technique. The investigators aimed to determine the rate of major cardiovascular events in patients treated by angioplasty for ULMD in a "real world" registry.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Registry in Patients With Unprotected Left Main Disease Treated by Percutaneous Coronary Intervention: The ALMA (Angioplasty of Left Main - lAriboisiere) Registry

Resource links provided by NLM:


Further study details as provided by Hopital Lariboisière:

Primary Outcome Measures:
  • Major cardiovascular events (MACCE) [ Time Frame: One year ] [ Designated as safety issue: No ]
    Major cardiovascular events (MACCE)were measured after 1 year follow-up. MACCE included all-cause of death, stroke, myocardial infarction, and repeat revascularizations. Non-Q-wave myocardial infarction was defined using universal definition with troponin I. Stent thrombosis was defined according to the Academic Research Consortium definition as definite, probable, or possible and as early or late after the index procedure. Repeat revascularization was composed of any repeat percutaneous intervention or surgical bypass.


Enrollment: 125
Study Start Date: January 2007
Study Completion Date: November 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Angioplasty of left main

Patients with:

  • stable or unstable angina and/or documented ischemia
  • de novo ≥50% stenosis in the left main stem referred for angioplasty

Detailed Description:

Current guidelines recommend coronary artery bypass graft surgery as the "gold standard" treatment in patients with unprotected left main disease. However, patients with ULMD and high surgical risk score or favourable anatomy are still referred for angioplasty. Recently, several studies and registries comparing surgery and percutaneous intervention with drug eluting stents report similar results regarding cardiovascular death and myocardial infarction in patients with multivessel coronary artery disease including unprotected left main disease.

The aim of the study is to evaluate major cardiovascular events in a "real world" registry.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients with stenosis of unprotected left main and schedulded angioplasty in the Department of Cardiology, Lariboisiere Hospital.

Criteria

Inclusion Criteria:

  • stable or unstable angina and/or documented ischemia
  • 50% de novo ULMD referred for angioplasty

Exclusion Criteria:

  • acute coronary syndrome with ST elevation,
  • cardiogenic shock or out of hospital cardiac arrest
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725373

Locations
France
Departement of Cardiology, Laribosiere Hospital, APHP
Paris, France, 75010
Sponsors and Collaborators
Hopital Lariboisière
Investigators
Study Director: Patrick Henry, MD-PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Dr Jean-Guillaume DILLINGER, Principal investigator - Medical Doctor in the Departement of Cardiology, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT01725373     History of Changes
Other Study ID Numbers: LRB-06-012
Study First Received: November 8, 2012
Last Updated: January 12, 2014
Health Authority: France: Ministry of Health

Keywords provided by Hopital Lariboisière:
left main, stent,angioplasty

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014