NCT01620320

Brief Summary

Left main stenosis use to be treated by bypass but with the improvement of angioplasty techniques, an increasing number of patients are submit to left main coronary angioplasty. Consequences of left main intra stent stenosis can be disastrous yet, for the moment, no precise recommendation concerning the follow up of these patients exist. The investigators ought to determine if stress echocardiography can predict left main intra stent stenosis as well (non inferiorly)as control angiography that use to be done.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

July 16, 2010

Last Update Submit

June 24, 2013

Conditions

Keywords

Left main coronary arteryCoronary artery diseaseStress echographyIntrastent stenosis

Outcome Measures

Primary Outcomes (1)

  • Correlation between stress echocardiography results for the detection of left main prosthesis stenosis with coronary angiogram results.

    9 to 12 months after left main angioplasty

Study Arms (1)

Stress echography

Nine to twelve months after their left main angioplasty, patients will go through a stress echo and then the usual control angiography (done routinely in most patient in our center). Patients will act as their own control.

Other: Stress echocardiography

Interventions

Patients able to exercise will have a treadmill test + echography; the others will have a dobutamine echography.

Also known as: Dobutamine echocardiography, Treadmill echocardiography
Stress echography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to teaching hospital or stent from community hospitals to teaching hospital and having left main angioplasty

You may qualify if:

  • patients over 18 years old able to give consent and having had left main angioplasty.

You may not qualify if:

  • Bypass on the left anterior descending coronary artery or left circumflex (" protected left main ")
  • Treating physician judge that angiography need to be done straightaway
  • Follow up elsewhere than the CHUS
  • Patient refusal
  • Pregnant women
  • Stress echo contraindication(Severe high blood pressure or malignant arrhythmia)or condition that limits interpretation (Left bundle branch block or pacemaker rhythm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Coronary Artery DiseaseConstriction, Pathologic

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Farand, Cardiologue

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 16, 2010

First Posted

June 15, 2012

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2013

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations