Left Main Coronary Artery DiseaseESTRIE-TCNCT01620320
Stress Echocardiography Versus Coronary Angiography for Left Main Stenosis Detection
An observational study of Left Main Coronary Artery Disease and Stenosis, run by Université de Sherbrooke at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Main Coronary Artery Disease, Stenosis
- What is being tested?
- Stress echocardiography
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Jul 2013
- 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: Patients presenting to teaching hospital or stent from community hospitals to teaching hospital and having left main angioplasty
Who may be able to join
- patients over 18 years old able to give consent and having had left main angioplasty.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Évaluation de l'Echographie de Stress Par Comparaison à la Coronarographie Comme Outil Non Invasif de détection de la resténose Intra endoprothèse du Tronc Commun
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.
Read the detailed description
All patients of the study will pass coronary angiogram and stress echocardiography (treadmill of dobutamine).
- Conditions
- Left Main Coronary Artery Disease, Stenosis
- Being tested
- Stress echocardiography
- Keywords
- Left main coronary artery, Coronary artery disease, Stress echography, Intrastent stenosis
- Medical subject headings
- Coronary Artery Disease, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress echocardiographyOther
Also called Dobutamine echocardiography, Treadmill echocardiography
Patients able to exercise will have a treadmill test + echography; the others will have a dobutamine echography.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between stress echocardiography results for the detection of left main prosthesis stenosis with coronary angiogram results.
Measured: 9 to 12 months after left main angioplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startJul 2010
- Primary completionJul 2012 (estimated)
- Study completionJul 2013 (estimated)
Why it stopped: No Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Main Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Farand, Université de Sherbrooke
- Investigators
- Paul Farand, Cardiologue, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620320
- Sponsor's protocol ID
- projet #10-011
- Acronym
- ESTRIE-TC
- Status last verified
- Jun 2013
- First submitted
- 16 Jul 2010
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Évaluation de l'Echographie de Stress Par Comparaison à la Coronarographie Comme Outil Non Invasif de détection de la resténose Intra endoprothèse du Tronc Commun
- ClinicalTrials.gov ID
- NCT01620320
- Acronym / sponsor ID
- ESTRIE-TC / projet #10-011
- Conditions
- Left Main Coronary Artery Disease, Stenosis
- Keywords
- Left main coronary artery, Coronary artery disease, Stress echography, Intrastent stenosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 15 Jun 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.
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.
Detailed description
All patients of the study will pass coronary angiogram and stress echocardiography (treadmill of dobutamine).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress echography | – | Other: Stress echocardiographyNine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to teaching hospital or stent from community hospitals to teaching hospital and having left main angioplasty
Key inclusion criteria (1 listed)
- patients over 18 years old able to give consent and having had left main angioplasty.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress echocardiographyAlso: Dobutamine echocardiography, Treadmill echocardiographyPatients able to exercise will have a treadmill test + echography; the others will have a dobutamine echography. | Other | Stress echography |
Primary outcome
Correlation between stress echocardiography results for the detection of left main prosthesis stenosis with coronary angiogram results.
Time frame: 9 to 12 months after left main angioplasty
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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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.
Paul Farand, Cardiologue principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Main Coronary Artery Disease and Stenosis, run by Université de Sherbrooke at 1 site in Canada.
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 6 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: withdrawn, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation between stress echocardiography results for the detection of left main prosthesis stenosis with coronary angiogram results. (time frame: 9 to 12 months after left main angioplasty). 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 26 Jun 2013.