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CompletedNCT02219815PREHABUpdated Oct 29, 2024Results posted

Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.

An interventional study of Prehab Intervention in Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement and Patients Waiting for Mitral Valve Repair or Replacement, sponsored by St. Boniface Hospital. Completed at 5 sites in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by St. Boniface Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
89
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education program at a community-based cardiac rehabilitation facility. Patients can wait for elective heart surgery for as long as 3-4 months. During this time, individuals are often fearful of making things worse, causing them to stop being active and further deteriorate their physical condition. This wait period presents a potential opportunity for health care providers to engage the patient to take control of their self-managed care prior to surgery with the intent of improving post-surgical outcomes. Patients randomized to the PREHAB intervention group will participate in supervised exercise twice per week in a program designed to improve physical functioning and exercise capacity. The investigators hypothesize that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will reduce frailty, improve exercise capacity, improve physical activity behaviour, improve in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and improve overall quality of life.

Read the detailed description

PREHAB will be a three centre prospective, randomized, open, blinded endpoint (PROBE) controlled trial using assessor blinding and intention-to-treat analysis. The study will be conducted at three academic, tertiary care hospitals (St. Boniface Hospital, Winnipeg, MB, Montreal Heart Institute. Montreal QC and Queen Elizabeth II Health Sciences Centre, Halifax, NS) and one non-academic hospital (Saint John Regional Health Centre, Saint John, NB) that perform cardiac surgery. These sites were chosen based on similar patient populations and surgical waitlist times. Additionally, each of these sites are partnered with one or more community-based cardiac rehabilitation (CR) centres, which are certified medical fitness facilities dedicated to improving the health of the community through health promotion, disease prevention and rehabilitation services. These facilities offer expert guidance from certified professionals, innovative health enhancement programs, and provide integrated medical, rehabilitative and fitness services. The investigators intend to recruit a total of 244 participants to the study (122 per study arm), anticipating a 20% dropout rate to achieve an eventual sample size of 194 participants.

Patients in the PREHAB group will receive, in addition to standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. This program will target both the physical and psycho-social-cognitive aspects of cardiac disease and frailty. In brief, participants will be required to complete an intake health status assessment by the CR team including a physiotherapist, cardiovascular nurse, and dietitian and complete a symptom-limited graded exercise stress test according to the American College of Sports Medicine Guidelines for Exercise Testing and Prescription 7th Edition. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. This has been shown to be safe and effective in unrepaired heart failure and elderly patients. PREHAB participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.

02

Conditions studied

  • Patients Waiting for Coronary Artery Bypass Graft Surgery
  • Patients Waiting for Aortic Valve Repair or Replacement
  • Patients Waiting for Mitral Valve Repair or Replacement
  • Patients Waiting for Combined Procedures. (CAGB and Valve)

Keywords

  • Preoperative Care
  • Exercise Therapy
  • Cardiac Surgery
  • Frailty
03

In context

Lead sponsor

St. Boniface Hospital is the lead sponsor of 32 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients aged 60 years and older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair/replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures
  • Patients with Clinical Frailty Score (CFS) ≥3 (vulnerable) and \< 7 (8 = very severely frail, approaching end-of-life or 9 = terminally ill) at time of acceptance for cardiac surgery
  • Patients with an estimated ≥ 6 week wait time

Exclusion criteria

Exclusion Criteria:

  • Patients who have unstable or recent unstable cardiac syndrome as defined by:

    1. Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms
    2. Critical left main (LM) coronary disease
    3. Hospitalization for arrhythmias, congestive heart failure or acute coronary syndrome prior to randomization

  • Patients who have severe left ventricular obstructive disease as defined by:

    1. Severe aortic or mitral stenosis (aortic or mitral valve area \<1.0cm2 or mean gradient > 40 mmHg or > 10 mmHg respectively)
    2. Dynamic left ventricular (LV) outflow obstruction
  • Patients who have demonstrated exercise induced ventricular arrhythmias or have experienced a recent hospitalization for arrhythmias
  • Patients who have cognitive deficits that would preclude rehabilitation
  • Patients who have physical limitations that would preclude rehabilitation
  • Patients who are unable to attend the Prehab program
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
89 participants (actual)

Study arms

  • No intervention
    Standard Care

    Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).

  • Experimental
    Prehab Intervention

    Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.

    Behavioral: Prehab Intervention

Interventions

  • BehavioralPrehab Intervention

    Pre-operative, structured exercise intervention.

06

What researchers measure

Primary outcomes

  1. Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.

    Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days

    Time frame: Post-surgery (approximately 9 weeks after baseline)

Secondary outcomes

  1. Baseline Exercise Capacity

    This measure will be assessed using the results of a 6 minute walk test.

    Time frame: baseline assessment - Study entry

  2. Preoperative Exercise Capacity

    This measure will be assessed using the results of a 6 minute walk test.

    Time frame: Pre-Surgery (approximately 8 weeks after baseline)

  3. 3-Month Exercise Capacity

    This measure will be assessed using the results of a 6 minute walk test.

    Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)

  4. 1-Year Exercise Capacity

    This measure will be assessed using the results of a 6 minute walk test.

    Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)

  5. Baseline Physical Activity Behaviour

    This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

    Time frame: baseline assessment - Study entry

  6. Preoperative Physical Activity Behaviour

    This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

    Time frame: Pre-Surgery (approximately 8 weeks after baseline)

  7. 3-Month Physical Activity Behaviour

    This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

    Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)

  8. 1-Year Physical Activity Behaviour

    This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

    Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)

  9. Baseline Health-Related Quality of Life

    This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

    Time frame: baseline assessment - Study entry

  10. Preoperatve Health-Related Quality of Life

    This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

    Time frame: Pre-Surgery (approximately 8 weeks after baseline)

  11. 3-Month Health-Related Quality of Life

    This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

    Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)

  12. 1-Year Health-Related Quality of Life

    This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

    Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)

  13. Baseline Frailty

    This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

    Time frame: baseline assessment - Study entry

  14. Preoperative Frailty

    This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

    Time frame: Pre-Surgery (approximately 8 weeks after baseline)

  15. 3-Month Frailty

    This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

    Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)

  16. 1-Year Frailty

    This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

    Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)

  17. Baseline Anxiety

    This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

    Time frame: Baseline Assessment - Study entry

  18. Preoperative Anxiety

    This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

    Time frame: Pre-Surgery Assessment (approximately 8 weeks after baseline)

  19. 3-Month Anxiety

    This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

    Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)

  20. 1-Year Anxiety

    This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

    Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)

  21. Baseline Depression

    This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

    Time frame: Baseline Assessment - Study entry

  22. Preoperative Depression

    This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

    Time frame: Pre-surgery Assessment ( 8 weeks after baseline)

  23. 3-Month Depression

    This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

    Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)

  24. 1 Year Depression

    This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

    Time frame: 1 year Post-Surgery (approximately 14 months after baseline)

  25. Postoperative Major Adverse Events

    Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.

    Time frame: Post-Surgery (approximately 9 weeks after baseline)

  26. Postoperative Cardiac Rehabilitation Attendance

    Will be assessed using administrative data from participating cardiac rehabilitation facilities.

    Time frame: Post-Surgery (approximately 20 weeks after baseline)

07

Results

Posted Oct 13, 2021
Limitations and caveats
1. Recruitment was only 89 participants from an expected sample size of 244 participants. This was a major limitation regarding data analysis. 2. Short cardiac surgery waitlists (i.e. surgery in less than 4 weeks) were impactful to study recruitment and intervention delivery

Participant flow

Participant flow — Overall Study
MilestoneStandard CarePrehab Intervention
Started4445
Post hospital discharge analysis4239
3 month post surgery3431
Completed2221
Not completed2224

Outcome measures

PrimaryProportion of Patients With Hospital Length of Stay Greater Than 7 Days.

Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days

Time frame:
Post-surgery (approximately 9 weeks after baseline)
Reported as:
Count of participants · Participants
Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.
ParticipantsStandard CarePrehab Intervention
Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.2016
SecondaryBaseline Exercise Capacity

This measure will be assessed using the results of a 6 minute walk test.

Time frame:
baseline assessment - Study entry

Results for this outcome have not been posted.

SecondaryPreoperative Exercise Capacity

This measure will be assessed using the results of a 6 minute walk test.

Time frame:
Pre-Surgery (approximately 8 weeks after baseline)

Results for this outcome have not been posted.

Secondary3-Month Exercise Capacity

This measure will be assessed using the results of a 6 minute walk test.

Time frame:
3 Months Post-Surgery (approximately 5 months after baseline)

Results for this outcome have not been posted.

Secondary1-Year Exercise Capacity

This measure will be assessed using the results of a 6 minute walk test.

Time frame:
1 Year Post-Surgery (approximately 14 months after baseline)

Results for this outcome have not been posted.

SecondaryBaseline Physical Activity Behaviour

This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

Time frame:
baseline assessment - Study entry

Results for this outcome have not been posted.

SecondaryPreoperative Physical Activity Behaviour

This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

Time frame:
Pre-Surgery (approximately 8 weeks after baseline)

Results for this outcome have not been posted.

Secondary3-Month Physical Activity Behaviour

This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

Time frame:
3 Months Post-Surgery (approximately 5 months after baseline)

Results for this outcome have not been posted.

Secondary1-Year Physical Activity Behaviour

This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

Time frame:
1 Year Post-Surgery (approximately 14 months after baseline)

Results for this outcome have not been posted.

SecondaryBaseline Health-Related Quality of Life

This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

Time frame:
baseline assessment - Study entry

Results for this outcome have not been posted.

SecondaryPreoperatve Health-Related Quality of Life

This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

Time frame:
Pre-Surgery (approximately 8 weeks after baseline)

Results for this outcome have not been posted.

Secondary3-Month Health-Related Quality of Life

This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

Time frame:
3 Months Post-Surgery (approximately 5 months after baseline)

Results for this outcome have not been posted.

Secondary1-Year Health-Related Quality of Life

This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

Time frame:
1 Year Post-Surgery (approximately 14 months after baseline)

Results for this outcome have not been posted.

SecondaryBaseline Frailty

This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

Time frame:
baseline assessment - Study entry

Results for this outcome have not been posted.

SecondaryPreoperative Frailty

This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

Time frame:
Pre-Surgery (approximately 8 weeks after baseline)

Results for this outcome have not been posted.

Secondary3-Month Frailty

This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

Time frame:
3 Months Post-Surgery (approximately 5 months after baseline)

Results for this outcome have not been posted.

Secondary1-Year Frailty

This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

Time frame:
1 Year Post-Surgery (approximately 14 months after baseline)

Results for this outcome have not been posted.

SecondaryBaseline Anxiety

This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

Time frame:
Baseline Assessment - Study entry

Results for this outcome have not been posted.

SecondaryPreoperative Anxiety

This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

Time frame:
Pre-Surgery Assessment (approximately 8 weeks after baseline)

Results for this outcome have not been posted.

Secondary3-Month Anxiety

This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

Time frame:
3 Months Post-Surgery (approximately 5 months after baseline)

Results for this outcome have not been posted.

Secondary1-Year Anxiety

This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

Time frame:
1 Year Post-Surgery (approximately 14 months after baseline)

Results for this outcome have not been posted.

SecondaryBaseline Depression

This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

Time frame:
Baseline Assessment - Study entry

Results for this outcome have not been posted.

SecondaryPreoperative Depression

This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

Time frame:
Pre-surgery Assessment ( 8 weeks after baseline)

Results for this outcome have not been posted.

Secondary3-Month Depression

This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

Time frame:
3 Months Post-Surgery (approximately 5 months after baseline)

Results for this outcome have not been posted.

Secondary1 Year Depression

This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

Time frame:
1 year Post-Surgery (approximately 14 months after baseline)

Results for this outcome have not been posted.

SecondaryPostoperative Major Adverse Events

Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.

Time frame:
Post-Surgery (approximately 9 weeks after baseline)

Results for this outcome have not been posted.

SecondaryPostoperative Cardiac Rehabilitation Attendance

Will be assessed using administrative data from participating cardiac rehabilitation facilities.

Time frame:
Post-Surgery (approximately 20 weeks after baseline)

Results for this outcome have not been posted.

Adverse events

Collected over 12 months. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard Care0/42 (0%)2/42 (4.8%)8/42 (19%)
Prehab Intervention0/39 (0%)1/39 (2.6%)3/39 (7.7%)
Most frequent serious events
Most frequent serious events
EventStandard CarePrehab Intervention
StrokeVascular disorders2/421/39
Most frequent other events
Most frequent other events
EventStandard CarePrehab Intervention
post operative DeliriumNervous system disorders8/423/39

Baseline characteristics

the baseline analysis was based on the completion of the primary outcome of hospital length of stay. Consented participants and participants in the analysis does differ. 8 participants were not involved in the analysis as they did not have surgery or had emergent surgery prior to intervention start.

Age, Categorical
Age, Categorical(Participants)Standard CarePrehab InterventionTotal
<=18 years000
Between 18 and 65 years11415
>=65 years313566
Age, Continuous
Age, Continuous(years)Standard CarePrehab InterventionTotal
Mean69.3 ± 5.271.4 ± 6.470.3 ± 5.9
Sex: Female, Male
Sex: Female, Male(Participants)Standard CarePrehab InterventionTotal
Female11516
Male313465
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Standard CarePrehab InterventionTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Standard CarePrehab InterventionTotal
Canada423981
08

Study locations

5 sites
  • St. Boniface General Hospital
    Winnipeg, Manitoba R2H2A6, Canada
  • Saint John Regional Hospital - New Brunswick Heart Centre
    Saint John, New Brunswick E2L4L2, Canada
  • Queen Elizabeth II Health Sciences Centre
    Halifax, Nova Scotia B3H3A7, Canada
  • Montreal Heart Institute
    Montreal, Quebec H1T 1C8, Canada
  • Laval University
    Quebec City, Quebec G1V4G5, Canada
09

References and documents

Publications

  • Kehler DS, Stammers AN, Tangri N, Hiebert B, Fransoo R, Schultz ASH, Macdonald K, Giacomontonio N, Hassan A, Legare JF, Arora RC, Duhamel TA. Systematic review of preoperative physical activity and its impact on postcardiac surgical outcomes. BMJ Open. 2017 Aug 11;7(8):e015712. doi: 10.1136/bmjopen-2016-015712. PubMed 28801404 ↗
  • Stammers AN, Kehler DS, Afilalo J, Avery LJ, Bagshaw SM, Grocott HP, Legare JF, Logsetty S, Metge C, Nguyen T, Rockwood K, Sareen J, Sawatzky JA, Tangri N, Giacomantonio N, Hassan A, Duhamel TA, Arora RC. Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial. BMJ Open. 2015 Mar 9;5(3):e007250. doi: 10.1136/bmjopen-2014-007250. PubMed 25753362 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 16, 2019
  • Informed consent form · Oct 20, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02219815
Lead sponsor
St. Boniface Hospital
Responsible party
Dr. Rakesh C. Arora (Medical Director, Intensive Care Cardiac Sciences, St. Boniface Hospital) — Principal investigator
First posted
Aug 19, 2014
Start date
Apr 2015
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Results posted
Oct 13, 2021
Last update
Oct 29, 2024

Study contacts

Rakesh Arora, MD
principal investigator · St. Boniface Hospital/University of Manitoba

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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