Myocardial InfarctionPhase 3NCT00336830
Improving Cardiac Rehabilitation Participation in Women and Men
A Phase 3 study testing MD-endorsed Cardiac Rehabilitation referral and Standard Cardiac Rehabilitation referral in people with Myocardial Infarction and Unstable Angina, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effect of a pre-discharge written personal endorsement to the patient by the patient's attending cardiologist or cardiac surgeon (MD endorsement) to take part in the Cardiac Rehabilitation and Secondary Prevention (CR) program, in addition to the standard CR referral… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Unstable Angina, Coronary Disease
- What is being tested?
- MD-endorsed Cardiac Rehabilitation referral and Standard Cardiac Rehabilitation referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,035 participants
- Where
- 1 siteCanada
- Study dates
- May 2003to Dec 2009
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is admitted to hospital for myocardial infarction (MI), unstable angina (UA), percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass surgery (CABS)
- Patient resides within 1 hour driving time from London
Who cannot join
- Inability to provide written informed consent or complete survey due to language or cognitive difficulties
- Previous cardiac rehabilitation participation
- Patient scheduled to undergo PTCA or CABS within two months following the index hospital discharge
- Inability to exercise due to musculoskeletal problems or previous or current stroke
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effect of a pre-discharge written personal endorsement to the patient by the patient's attending cardiologist or cardiac surgeon (MD endorsement) to take part in the Cardiac Rehabilitation and Secondary Prevention (CR) program, in addition to the standard CR referral, compared to the standard CR referral alone, on CR program enrollment within 2 months of index hospital discharge following admission for myocardial infarction, unstable angina, coronary angioplasty, or coronary artery bypass.
Read the detailed description
There is compelling evidence that a comprehensive CR program comprising the delivery of lifestyle modifying education will reduce mortality, morbidity and improve quality of life in patients following myocardial infarction, angioplasty or, coronary artery bypass. However, less than 20% of eligible patients participate in CR programs. This study will look at a method of potentially improving enrollment and adherence to a CR program. It is expected that patients who receive the MD-endorsed referral will be more likely to attend the initial Orientation appointment and more closely adhere to the 6-month comprehensive CR program, as compared to the patients who receive a standard CR referral alone.
- Conditions
- Myocardial Infarction, Unstable Angina, Coronary Disease
- Being tested
- MD-endorsed Cardiac Rehabilitation referral, Standard Cardiac Rehabilitation referral
- Keywords
- Cardiac Rehabilitation, Improving Cardiac Rehabilitation Participation, coronary angioplasty, coronary artery bypass surgery
- Medical subject headings
- Myocardial Infarction, Angina, Unstable, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-endorsed Cardiac Rehabilitation referralBehavioural
Also called MD endorsed referral to Cardiac Rehabilitation
Note to patient with general description of the Cardiac Rehabilitation program with signature and strong recommendation from attending physician.
Standard Cardiac Rehabilitation referralBehavioural
Also called Standard Referral to Cardiac Rehabilitation
Note to patient with general description of the Cardiac Rehabilitation program without signature or recommendation from attending physician.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Comparator without MD endorsement of Cardiac Rehabilitation Receives: Behavioral: Standard Cardiac Rehabilitation referral |
| MD Endorsment of CR | Experimental | Provided with MD endorsement of participation in Cardiac Rehabilitation Receives: Behavioral: MD-endorsed Cardiac Rehabilitation referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at initial CR orientation appointment within 2 months of index hospital discharge
Measured: 3 months
Secondary outcomes (3)
Impact of MD endorsement on number of patients attending CR program
Measured: 3 months
Number of patients who continue to adhere to the 6-month CR program beyond the initial CR orientation appointment
Measured: 8 months
Impact of other patient variables and how they influence participation in a CR program
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
- Study startMay 2003
- Primary completionJun 2007
- Study completionDec 2009
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.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), AstraZeneca
- Responsible party
- Principal investigator, Neville Suskin, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Neville Suskin, MBChB, MSc, Principal investigator, University of Western Ontario & London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336830
- Sponsor's protocol ID
- R-02-037
- Other IDs
- CIHR 56926
- Status last verified
- Mar 2014
- First submitted
- 13 Jun 2006
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiac Rehabilitation Participation in Women and Men
- ClinicalTrials.gov ID
- NCT00336830
- Acronym / sponsor ID
- R-02-037
- Conditions
- Myocardial Infarction, Unstable Angina, Coronary Disease
- Keywords
- Cardiac Rehabilitation, Improving Cardiac Rehabilitation Participation, coronary angioplasty, coronary artery bypass surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,035 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), AstraZeneca
- Study start
- May 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Jun 2006 (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 determine the effect of a pre-discharge written personal endorsement to the patient by the patient's attending cardiologist or cardiac surgeon (MD endorsement) to take part in the Cardiac Rehabilitation and Secondary Prevention (CR) program, in addition to the standard CR referral, compared to the standard CR referral alone, on CR program enrollment within 2 months of index hospital discharge following admission for myocardial infarction, unstable angina, coronary angioplasty, or coronary artery bypass.
Detailed description
There is compelling evidence that a comprehensive CR program comprising the delivery of lifestyle modifying education will reduce mortality, morbidity and improve quality of life in patients following myocardial infarction, angioplasty or, coronary artery bypass. However, less than 20% of eligible patients participate in CR programs. This study will look at a method of potentially improving enrollment and adherence to a CR program. It is expected that patients who receive the MD-endorsed referral will be more likely to attend the initial Orientation appointment and more closely adhere to the 6-month comprehensive CR program, as compared to the patients who receive a standard CR referral alone.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Standard Cardiac Rehabilitation referralComparator without MD endorsement of Cardiac Rehabilitation |
| MD Endorsment of CR | Experimental | Behavioral: MD-endorsed Cardiac Rehabilitation referralProvided with MD endorsement of participation in Cardiac Rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is admitted to hospital for myocardial infarction (MI), unstable angina (UA), percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass surgery (CABS)
- Patient resides within 1 hour driving time from London
Key exclusion criteria (4 listed)
- Inability to provide written informed consent or complete survey due to language or cognitive difficulties
- Previous cardiac rehabilitation participation
- Patient scheduled to undergo PTCA or CABS within two months following the index hospital discharge
- Inability to exercise due to musculoskeletal problems or previous or current stroke
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 |
|---|---|---|
| MD-endorsed Cardiac Rehabilitation referralAlso: MD endorsed referral to Cardiac RehabilitationNote to patient with general description of the Cardiac Rehabilitation program with signature and strong recommendation from attending physician. | Behavioural | MD Endorsment of CR |
| Standard Cardiac Rehabilitation referralAlso: Standard Referral to Cardiac RehabilitationNote to patient with general description of the Cardiac Rehabilitation program without signature or recommendation from attending physician. | Behavioural | Usual Care |
Primary outcome
Attendance at initial CR orientation appointment within 2 months of index hospital discharge
Time frame: 3 months
3 secondary outcomes
Impact of MD endorsement on number of patients attending CR program
Time frame: 3 months
Number of patients who continue to adhere to the 6-month CR program beyond the initial CR orientation appointment
Time frame: 8 months
Impact of other patient variables and how they influence participation in a CR program
Time frame: 8 months
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 27 Mar 2014.
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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.
Neville Suskin, MBChB, MSc principal investigator
University of Western Ontario & London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MD-endorsed Cardiac Rehabilitation referral and Standard Cardiac Rehabilitation referral in people with Myocardial Infarction and Unstable Angina, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 2 inclusion and 4 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 27 Mar 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Attendance at initial CR orientation appointment within 2 months of index hospital discharge (time frame: 3 months). 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 27 Mar 2014.