Myocardial InfarctionROSENCT01086124
Objective Systolic Function Recuperation Assessed by Echocardiography
An observational study of Myocardial Infarction and Left Ventricular Systolic Dysfunction, run by Paul Farand at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate left ventricular systolic ejection fraction and anterior or apical akinesis 1 month and 3 months after a myocardial infarction treated with primary PCI to determine whether improvement at 1 month differs from improvement at 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Left Ventricular Systolic Dysfunction, Anterior Akinesis
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Dec 2012
- 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 sent from community hopitals to teaching hospital for primary PCI
Who may be able to join
- Older than 18 years old
- ST elevation myocardial infarction treated with primary PCI
- Anterior or apical akinesis and left ventricular ejection fraction ≤ 45% on early echocardiography (48hours - 7 days post myocardial infarction)
- Initial ECG showing at least 1 mm ST elevation in 2 leads corresponding to the same vascular territory
Who cannot join
- Known left ventricular systolic dysfunction before myocardial infarction
- Left bundle branch block
- Vital prognosis less than 6 months
- Cardiogenic shock
- Rescue PCI
- Sub-optimal echocardiographic imaging (contrast use is allowed)
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- Significant valvular heart disease (moderate or severe)
- Surgical revascularization
- Pregnancy or breastfeeding
- Incapacity to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
The purpose of this study is to evaluate left ventricular systolic ejection fraction and anterior or apical akinesis 1 month and 3 months after a myocardial infarction treated with primary PCI to determine whether improvement at 1 month differs from improvement at 3 months.
- Conditions
- Myocardial Infarction, Left Ventricular Systolic Dysfunction, Anterior Akinesis, Apical Akinesis
- Keywords
- echocardiography, ST elevation myocardial infarction, Heart failure, Coronary artery disease, Cardiovascular diseases
- Medical subject headings
- Myocardial Infarction, Ventricular Dysfunction, Left, ST Elevation Myocardial Infarction, Heart Failure, Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Echocardiography 1 month | Patients will all have an echocardiography 1 month post myocardial infarction and 3 months post myocardial infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction recuperation 1 month post myocardial infarction
Left ventricular ejection fraction recuperation 1 month post myocardial infarction as compared with the left ejection fraction 3 months post myocardial infarction
Measured: 1 month post myocardial infarction
Secondary outcomes (1)
Anterior and apical akinesis recuperation 1 month post myocardial infarction
Anterior and apical akinesis recuperation 1 month post myocardial infarction as compared with 3 months post myocardial infarction
Measured: 1 month post myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Farand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Farand, Université de Sherbrooke
- Investigators
- Paul Farand, md, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086124
- Sponsor's protocol ID
- 10-010
- Acronym
- ROSE
- Status last verified
- Jul 2013
- First submitted
- 11 Mar 2010
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Systolic Function Recuperation Assessed by Echocardiography
- ClinicalTrials.gov ID
- NCT01086124
- Acronym / sponsor ID
- ROSE / 10-010
- Conditions
- Myocardial Infarction, Left Ventricular Systolic Dysfunction, Anterior Akinesis, Apical Akinesis
- Keywords
- echocardiography, ST elevation myocardial infarction, Heart failure, Coronary artery disease, Cardiovascular diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Paul FarandUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Mar 2010 (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.
The purpose of this study is to evaluate left ventricular systolic ejection fraction and anterior or apical akinesis 1 month and 3 months after a myocardial infarction treated with primary PCI to determine whether improvement at 1 month differs from improvement at 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiography 1 month | – | –Patients will all have an echocardiography 1 month post myocardial infarction and 3 months post myocardial infarction |
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 sent from community hopitals to teaching hospital for primary PCI
Key inclusion criteria (4 listed)
- Older than 18 years old
- ST elevation myocardial infarction treated with primary PCI
- Anterior or apical akinesis and left ventricular ejection fraction ≤ 45% on early echocardiography (48hours - 7 days post myocardial infarction)
- Initial ECG showing at least 1 mm ST elevation in 2 leads corresponding to the same vascular territory
Key exclusion criteria (10 listed)
- Known left ventricular systolic dysfunction before myocardial infarction
- Left bundle branch block
- Vital prognosis less than 6 months
- Cardiogenic shock
- Rescue PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left ventricular ejection fraction recuperation 1 month post myocardial infarction
Time frame: 1 month post myocardial infarction
Left ventricular ejection fraction recuperation 1 month post myocardial infarction as compared with the left ejection fraction 3 months post myocardial infarction
1 secondary outcome
Anterior and apical akinesis recuperation 1 month post myocardial infarction
Time frame: 1 month post myocardial infarction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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, md 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 Myocardial Infarction and Left Ventricular Systolic Dysfunction, run by Paul Farand 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 8 Jul 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Left ventricular ejection fraction recuperation 1 month post myocardial infarction (time frame: 1 month post myocardial infarction). 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 8 Jul 2013.