Myocardial InfarctionEVADENCT03534817
Early Versus Standard Access Cardiac Rehabilitation to Counter Ventricular Remodeling Post-MI (EVADE)
A study testing Early Access CR in people with Myocardial Infarction, run by University of Saskatchewan at 2 sites in Canada.
Trial summary
BACKGROUND: Cardiac rehabilitation (CR) is an outpatient chronic disease management program delivering secondary prevention, which is proven to reduce morbidity and mortality. The Canadian Cardiovascular Society Access to Care working group recommends patients access CR "preferably" within 2-7 days following… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Early Access CR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 8 Jan 2018to 31 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- have a cardiologist-diagnosed non ST-segment elevation MI (NSTEMI) or ST-segment elevation MI (STEMI) identified as low risk based on the Global Registry for Acute Coronary Events (GRACE) risk score;
- have angiographic evidence of revascularization of the infarct-related artery that is defined as ≥80% patency;
- have an ejection fraction ≥35% (to exclude patients needing a cardioverter defibrillator) and <50% (consistent with impaired heart pump function);
- reside within 100 km (1 hour travel time) of Saskatoon/Edmonton city limits;
- have been approved to attend CR by their attending physician.
Who cannot join
- have been hospitalized for a previous MI
- have a condition that precludes walk testing;
- have a contra-indication for cardiac MRI (i.e., pacemaker, pregnancy);
- index hospitalization >10 days;
- undergo coronary artery bypass grafting;
- does not undergo coronary angiography.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G 2B7
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5B2
About this study
Official title: Early Versus Standard Access Cardiac Rehabilitation to Counter Ventricular Remodeling Post-MI (EVADE): a Pilot-Feasibility Study.
BACKGROUND: Cardiac rehabilitation (CR) is an outpatient chronic disease management program delivering secondary prevention, which is proven to reduce morbidity and mortality. The Canadian Cardiovascular Society Access to Care working group recommends patients access CR "preferably" within 2-7 days following percutaneous intervention for myocardial infarction (MI), but that 30-60 days is "acceptable". Despite these benchmarks, in practice patients access CR up to 90 days post-treatment in Canada. This is disconcerting given the detrimental impacts of delayed access to CR. These include ventricular remodeling (i.e., ventricular enlargement and reduced pump function), lower CR use, less post-CR exercise, among others. Accordingly, EVADE will be the first randomized controlled trial (RCT) to test the effects of early access CR (1-week post-discharge to first CR visit) compared to standard access CR (7-weeks post-discharge to first CR visit) in ameliorating these concerns.
AIMS \& HYPOTHESIS: The primary aim is to compare ventricular remodeling as defined by the change in end-systolic volume at 1-year in participants randomized to early versus standard access CR. The secondary aims are: (1) to compare post-CR exercise adherence by accelerometry, exercise capacity by 6-minute walk test distance, and health-related quality of life (HRQL) at 1-year in participants randomized to early versus standard access CR; (2) to compare CR program session attendance in participants randomized to early versus standard access CR; and (3) to assess biomarkers of ventricular remodeling in participants randomized to early versus standard access CR.
Read more
The final aims are to explore more immediate health benefits associated with early versus standard access CR. Accordingly, at 6 months following hospital discharge the investigators will measure end-systolic volume, exercise adherence, exercise capacity, biomarkers of ventricular remodeling, and HRQL. The investigators will also explore hospitalization for any cause of death at 1 year in order to inform future research.
The overall hypothesis is that early access CR will be associated with less ventricular remodeling, increased CR attendance and post-CR exercise adherence, increased exercise capacity, and greater HRQL.
DESIGN: EVADE will be a two-centre, 2 parallel-arm, single-blinded RCT. Participants will be recruited through coronary care units following treatment for MI from the Royal University Hospital in Saskatoon, Saskatchewan and the University of Alberta Hospital in Edmonton. The University of Alberta Research Electronic Data Capture (REDCap) online database will randomize (1:1) participants (allocation concealed). A total of 60 participants will be enrolled: 30 participants will each be allocated to early access and standard access CR.
IMPACT: In the first prospective multicentre trial of its kind, EVADE will test an innovative post-MI rehabilitation strategy that has the potential to demonstrate the superior benefits of early access CR for attenuating ventricular remodeling, and increasing CR attendance, post-CR exercise adherence, exercise capacity, and HRQL. The results from EVADE would encourage the Canadian CR community to consider early access CR to further enhance readily available and existing CR programs. The knowledge gained from EVADE will inform clinical decision-making practices, influence future CR guidelines and policy, and will contribute to the ongoing goal of improving efficiency and effectiveness of the Canadian health care system.
- Conditions
- Myocardial Infarction
- Being tested
- Early Access CR
- Keywords
- Cardiac Rehabilitation, Early Access Cardiac Rehabilitation, Cardiac Rehabilitation Adherence, Myocardial Infarction, Ventricular Remodeling
- Medical subject headings
- Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Access CRBehavioural
Participants in the Early Access CR group will begin CR within 1-week post-hospital discharge following their MI, as opposed to Standard Access CR group which begins 7-weeks post-hospital discharge, and the Canadian average (10-14 weeks post-hospital discharge). No further intervention or differentiation between groups is applied; the actual CR program is standardized between groups, and follows the guidelines regularly practiced by the institution.
| Study group | Role | What they receive |
|---|---|---|
| Early Access CR | Experimental | Participants begin cardiac rehabilitation (CR) after 1-week following discharge post-MI. Receives: Behavioral: Early Access CR |
| Standard Access CR | No intervention | Participants begin CR after 7-weeks following discharge post-MI, similar to the average Canadian wait time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ventricular remodeling from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
End-diastolic volume (in milliliters) will be the primary marker of ventricular remodeling, and will be measured using clinical-grade cardiac magnetic resonance imaging (MRI).
Measured: A repeated measures approach will be taken for the primary outcome: before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI.
Secondary outcomes (19)
Change in end-systolic volume (in milliliters) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
End-systolic volume will indicate change in ventricular systolic function, which in turn indicates functional ventricular remodeling. End-systolic volume will be measured using clinical-grade cardiac magnetic resonance imaging (MRI).
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in stroke volume (in milliliters) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Stroke volume will indicate change in ventricular function, which in turn indicates functional ventricular remodeling. Stroke volume will be measured using clinical-grade cardiac magnetic resonance imaging (MRI).
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in ejection fraction (percentage) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Ejection fraction will indicate change in ventricular function, which in turn indicates functional ventricular remodeling. Ejection fraction will be measured using clinical-grade cardiac magnetic resonance imaging (MRI).
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in MI-related cardiac damage from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
MI-related cardiac damage will be measured using clinical-grade cardiac magnetic resonance imaging (MRI).
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in metalloproteinase-9 (MMP-9) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
MMP-9 levels (nanogram/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in high-sensitivity C-reactive protein (hsCRP) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
hsCRP levels (milligram/liter) will be analysed from blood samples taken by a registered phlebotomist.
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in brain-type natriuretic peptide (BNP) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
BNP levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in soluble receptor for advanced glycation end-products (sRAGE) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
sRAGE levels (picograms/milliliter) will be analysed from blood samples taken by a registered phlebotomist.
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in exercise capacity from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Participants will complete a 6-minute walk test; participants will walk for 6 minutes and will be encouraged to walk as fast as possible without running. The distance covered will be their score.
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in perceived health-related quality of life from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
The Short Form Health Survey (SF-36) evaluates and scores a participant's perceived quality of life with a numerical score on a scale. The overall score (range 0-100, mean) is an average of the subscales, which include the physical function score (range 0-100, mean of scores), quality of life limitations due to physical health (range 0-100, mean of scores), quality of life limitations due to emotional problems (range 0-100, mean of scores), energy levels score (range 0-100, mean of scores), emotional well-being (range 0-100, mean of scores), social functioning (range 0-100, mean of scores), pain (range 0-100, mean of scores), and general health (range 0-100, mean of scores). For the overall scale and the subscales, a higher value represents higher perceived health-related quality of life and a better outcome.
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI.
Change in heart-related anxiety from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
The Heart-Related Anxiety questionnaire evaluates and scores a participant's perceived anxiety related to their heart condition with a numerical score on a scale. The scale has 18-items scoring 0-4, and the measure's total score is the sum of scores (range 0-72) with a lower score representing less anxiety and a better outcome.
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI.
Change in hospital-related anxiety and depression from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
The Hospital Anxiety and Depression Scale (HADS) evaluates and scores a participant's perceived anxiety and depression following hospitalization with a numerical score on a scale. The questionnaire has 14-items total, 7 anxiety and 7 depression related questions, each scoring 0-3. The questionnaire has two subscales; anxiety (range 0-21) and depression (0-21). The item scores are summed to give the subscale score, with a lower value representing less anxiety or less depression and better outcomes.
Measured: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI.
Exercise history
The Godin Leisure Time Exercise Questionnaire (modified) scores a participant's recreational physical activity levels outside of employment within the past 4 weeks. This questionnaire will capture and account for physical activity performed prior to commencing CR. This questionnaire is not a scale as it does not have a maximum value, thus the range is not provided. It provides a score based by summing the number of bouts of light, moderate, and heavy physical activity, increasing the relative contribution of exercise intensity by adding a multiplier to the number of exercise bouts depending upon the intensity (i.e., multiply by 9 for heavy, by 5 for moderate, and by 3 for light activity). E.g., With 3 heavy exercise sessions, 6 moderate sessions, and 14 light sessions, the total leisure activity score = (9 × 3) + (5 × 6) + (3 × 14) = 27 + 30 + 42 = 99. A higher score represents a greater physical activity volume and a better outcome.
Measured: On the first visit to CR.
Change in post-CR exercise adherence (exercise duration in minutes) from the end of the 3 month CR program, to 6-months (immediate change), 9-months (immediate change), and 12-months post-MI (long-term change).
Tri-axial accelerometers will be worn for 7 consecutive days, 24 hours a day. The average daily minutes of moderate-to-vigorous physical activity will be recorded and calculated.
Measured: Before the end of 3 month CR program (within the last two weeks of their program); at 6 months post-MI; at 9-months post-MI; at 12 months post-MI.
Change in post-CR exercise adherence (daily steps) from the end of the 3 month CR program, to 6-months (immediate change), 9-months (immediate change), and 12-months post-MI (long-term change).
Tri-axial accelerometers will be worn for 7 consecutive days, 24 hours a day. The average daily minutes of moderate-to-vigorous physical activity will be recorded and calculated.
Measured: Before the end of 3 month CR program (within the last two weeks of their program); at 6 months post-MI; at 9-months post-MI; at 12 months post-MI.
CR Attendance
Participants attendance will be recorded as number of session per week.
Measured: At the end of 3 month CR program.
CR Adherence
Participants will keep a log of their CR exercise type, duration, and intensity which will be given to investigators at the end of the CR program.
Measured: At the end of 3 month CR program.
Hospitalization
During the final data collection visit, the participant will report all unanticipated hospital and emergency department visits during the last year since their MI. Study investigators will also do a search in the health region of hospitalization and emergency visits.
Measured: 12-months post-MI.
Death
If the participant has deceased prior to the end of the trial (i.e., 12-months post MI), this will be recorded.
Measured: 12-months post-MI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start8 Jan 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: COVID-19
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Saskatchewan Health Research Foundation, Royal University Hospital Foundation, University of Alberta
- Responsible party
- Principal investigator, Corey Tomczak, University of Saskatchewan
- Investigators
- David (Ian) Paterson, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534817
- Sponsor's protocol ID
- USaskatchewan-EVADE
- Acronym
- EVADE
- Status last verified
- Nov 2021
- First submitted
- 16 Jan 2018
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Standard Access Cardiac Rehabilitation to Counter Ventricular Remodeling Post-MI (EVADE): a Pilot-Feasibility Study.
- ClinicalTrials.gov ID
- NCT03534817
- Acronym / sponsor ID
- EVADE / USaskatchewan-EVADE
- Conditions
- Myocardial Infarction
- Keywords
- Cardiac Rehabilitation, Early Access Cardiac Rehabilitation, Cardiac Rehabilitation Adherence, Myocardial Infarction, Ventricular Remodeling
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Saskatchewan Health Research Foundation, Royal University Hospital Foundation, University of Alberta
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 May 2018 (actual)
- 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.
BACKGROUND: Cardiac rehabilitation (CR) is an outpatient chronic disease management program delivering secondary prevention, which is proven to reduce morbidity and mortality. The Canadian Cardiovascular Society Access to Care working group recommends patients access CR "preferably" within 2-7 days following percutaneous intervention for myocardial infarction (MI), but that 30-60 days is "acceptable". Despite these benchmarks, in practice patients access CR up to 90 days post-treatment in Canada. This is disconcerting given the detrimental impacts of delayed access to CR. These include ventricular remodeling (i.e., ventricular enlargement and reduced pump function), lower CR use, less post-CR exercise, among others. Accordingly, EVADE will be the first randomized controlled trial (RCT) to test the effects of early access CR (1-week post-discharge to first CR visit) compared to standard access CR (7-weeks post-discharge to first CR visit) in ameliorating these concerns.
AIMS \& HYPOTHESIS: The primary aim is to compare ventricular remodeling as defined by the change in end-systolic volume at 1-year in participants randomized to early versus standard access CR. The secondary aims are: (1) to compare post-CR exercise adherence by accelerometry, exercise capacity by 6-minute walk test distance, and health-related quality of life (HRQL) at 1-year in participants randomized to early versus standard access CR; (2) to compare CR program session attendance in participants randomized to early versus standard access CR; and (3) to assess biomarkers of ventricular remodeling in participants randomized to early versus standard access CR.
The final aims are to explore more immediate health benefits associated with early versus standard access CR. Accordingly, at 6 months following hospital discharge the investigators will measure end-systolic volume, exercise adherence, exercise capacity, biomarkers of ventricular remodeling, and HRQL. The investigators will also explore hospitalization for any cause of death at 1 year in order to inform future research.
The overall hypothesis is that early access CR will be associated with less ventricular remodeling, increased CR attendance and post-CR exercise adherence, increased exercise capacity, and greater HRQL.
DESIGN: EVADE will be a two-centre, 2 parallel-arm, single-blinded RCT. Participants will be recruited through coronary care units following treatment for MI from the Royal University Hospital in Saskatoon, Saskatchewan and the University of Alberta Hospital in Edmonton. The University of Alberta Research Electronic Data Capture (REDCap) online database will randomize (1:1) participants (allocation concealed). A total of 60 participants will be enrolled: 30 participants will each be allocated to early access and standard access CR.
IMPACT: In the first prospective multicentre trial of its kind, EVADE will test an innovative post-MI rehabilitation strategy that has the potential to demonstrate the superior benefits of early access CR for attenuating ventricular remodeling, and increasing CR attendance, post-CR exercise adherence, exercise capacity, and HRQL. The results from EVADE would encourage the Canadian CR community to consider early access CR to further enhance readily available and existing CR programs. The knowledge gained from EVADE will inform clinical decision-making practices, influence future CR guidelines and policy, and will contribute to the ongoing goal of improving efficiency and effectiveness of the Canadian health care system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Access CR | Experimental | Behavioral: Early Access CRParticipants begin cardiac rehabilitation (CR) after 1-week following discharge post-MI. |
| Standard Access CR | No intervention | –Participants begin CR after 7-weeks following discharge post-MI, similar to the average Canadian wait time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have a cardiologist-diagnosed non ST-segment elevation MI (NSTEMI) or ST-segment elevation MI (STEMI) identified as low risk based on the Global Registry for Acute Coronary Events (GRACE) risk score;
- have angiographic evidence of revascularization of the infarct-related artery that is defined as ≥80% patency;
- have an ejection fraction ≥35% (to exclude patients needing a cardioverter defibrillator) and <50% (consistent with impaired heart pump function);
- reside within 100 km (1 hour travel time) of Saskatoon/Edmonton city limits;
- have been approved to attend CR by their attending physician.
Key exclusion criteria (6 listed)
- have been hospitalized for a previous MI
- have a condition that precludes walk testing;
- have a contra-indication for cardiac MRI (i.e., pacemaker, pregnancy);
- index hospitalization >10 days;
- undergo coronary artery bypass grafting;
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 |
|---|---|---|
| Early Access CRParticipants in the Early Access CR group will begin CR within 1-week post-hospital discharge following their MI, as opposed to Standard Access CR group which begins 7-weeks post-hospital discharge, and the Canadian average (10-14 weeks post-hospital discharge). No further intervention or differentiation between groups is applied; the actual CR program is standardized between groups, and follows the guidelines regularly practiced by the institution. | Behavioural | Early Access CR |
Primary outcome
Change in ventricular remodeling from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: A repeated measures approach will be taken for the primary outcome: before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI.
End-diastolic volume (in milliliters) will be the primary marker of ventricular remodeling, and will be measured using clinical-grade cardiac magnetic resonance imaging (MRI).
19 secondary outcomes
Change in end-systolic volume (in milliliters) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in stroke volume (in milliliters) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in ejection fraction (percentage) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in MI-related cardiac damage from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in metalloproteinase-9 (MMP-9) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in high-sensitivity C-reactive protein (hsCRP) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in brain-type natriuretic peptide (BNP) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in soluble receptor for advanced glycation end-products (sRAGE) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in exercise capacity from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI
Change in perceived health-related quality of life from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI.
Change in heart-related anxiety from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI.
Change in hospital-related anxiety and depression from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).
Time frame: Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI.
Exercise history
Time frame: On the first visit to CR.
Change in post-CR exercise adherence (exercise duration in minutes) from the end of the 3 month CR program, to 6-months (immediate change), 9-months (immediate change), and 12-months post-MI (long-term change).
Time frame: Before the end of 3 month CR program (within the last two weeks of their program); at 6 months post-MI; at 9-months post-MI; at 12 months post-MI.
Change in post-CR exercise adherence (daily steps) from the end of the 3 month CR program, to 6-months (immediate change), 9-months (immediate change), and 12-months post-MI (long-term change).
Time frame: Before the end of 3 month CR program (within the last two weeks of their program); at 6 months post-MI; at 9-months post-MI; at 12 months post-MI.
CR Attendance
Time frame: At the end of 3 month CR program.
CR Adherence
Time frame: At the end of 3 month CR program.
Hospitalization
Time frame: 12-months post-MI.
Death
Time frame: 12-months post-MI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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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.
David (Ian) Paterson, PhD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Access CR in people with Myocardial Infarction, run by University of Saskatchewan at 2 sites 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 5 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: paused, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Change in ventricular remodeling from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change). (time frame: A repeated measures approach will be taken for the primary outcome: before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI.). 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 11 Nov 2021.