DeathPhase 3NCT01328912
Remote Ischemic Preconditioning in High Risk Cardiovascular Surgery Patients
A Phase 3 study testing Remote ischemic preconditioning stimulus in people with Death and Stroke, run by Queen's University at 1 site in Canada.
Trial summary
Remote ischemic preconditioning (RIPC) occurs when a tissue (ex. heart) becomes less vulnerable to an ischemic insult if a remote tissue (ex. arm) has had previous exposure to a period of ischemia and reperfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Stroke, Low Cardiac Output Syndrome
- What is being tested?
- Remote ischemic preconditioning stimulus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 429 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Feb 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing either cardiac or vascular surgical procedures and are deemed to be at increased risk of suffering adverse ischemia-related events (judged by pre-operative evidence of clinical ischemic conditions, pre-operative screening indicating cardiovascular disease or undergoing higher-risk surgery).
Who cannot join
- Will not include emergency cases, patients with known vascular disease (ex. arterial occlusive disease, arterio-venous shunts) or neurologic disease affecting the upper limb and patients unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Ischemic Preconditioning in High Risk Cardiovascular Surgery Patients: A Randomized Controlled Trial
Remote ischemic preconditioning (RIPC) occurs when a tissue (ex. heart) becomes less vulnerable to an ischemic insult if a remote tissue (ex. arm) has had previous exposure to a period of ischemia and reperfusion. A beneficial effect of RIPC has been demonstrated in several randomized studies in patients undergoing cardiac and vascular surgery, as well as interventional cardiac procedures such as angioplasty. They have shown improvements in cardiac, renal, neurologic and respiratory function. Most have focused on surrogate outcomes, such as biochemical markers of cardiac and renal function in low-risk patients. No trials have investigated only high-risk patients or been designed to detect clinical outcomes.
This study is a randomized-controlled trial powered to detect clinical events in a high-risk cohort undergoing cardiovascular surgery. Patients will be randomized to RIPC (exposed to cycles of inflation of a blood pressure cuff on the upper arm prior to undergoing surgery) or control (no ischemic stimulus).
Read more
The investigators hypothesize this population will demonstrate lower rates of adverse ischemic events. The investigators also intend to sample biochemical markers to better elucidate the mechanism of RIPC and generate hypotheses for future studies and interventions. Post-operatively the investigators will monitor for adverse clinical outcomes including cardiac, renal, pulmonary and neurologic injury.
RIPC is simple, inexpensive and easily reproducible and there have been no reports of adverse consequences. Post-operative ischemic events such as stroke, myocardial infarction, cardiac, renal and respiratory failure affect patient survival and quality of life, and represent a sizeable financial burden to health care. If beneficial effects of RIPC are demonstrated, it will be widely applicable to the entire population of cardiac and vascular patients resulting in a widely-implemented change in practice.
- Conditions
- Death, Stroke, Low Cardiac Output Syndrome, Myocardial Infarction, Renal Failure, Pulmonary Failure
- Being tested
- Remote ischemic preconditioning stimulus, control
- Keywords
- ischemic preconditioning, cardiac surgery, vascular surgery
- Medical subject headings
- Death, Stroke, Cardiac Output, Low, Myocardial Infarction, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioning stimulusOther
The intervention will consist of 3 cycles of 5 minutes of upper limb ischemia. The RIPC stimulus will be performed using a blood pressure cuff placed on the upper arm inflated above systemic pressure to 200 mmHg for 5 minutes, then deflated for 5 minutes. Ischemia will be assured with the use of a saturation probe on the digit of the involved arm.
controlOther
These patients are randomized to placebo, thus they will no undergo the RIPC stimulus.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic preconditioning stimulus | Experimental | Not described Receives: Other: Remote ischemic preconditioning stimulus |
| Control | Placebo comparator | Not described Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be a composite of clinical MACE (Multiple Adverse Cardiovascular Events), incorporating all-cause mortality, myocardial infarction, stroke, respiratory failure, acute renal failure and low cardiac output syndrome
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startFeb 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeathStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Darrin Payne, Queen's University
- Investigators
- Darrin Payne, MD, Principal investigator, Queen's University / Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328912
- Sponsor's protocol ID
- 6576
- Status last verified
- Feb 2016
- First submitted
- 31 Mar 2011
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning in High Risk Cardiovascular Surgery Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01328912
- Acronym / sponsor ID
- 6576
- Conditions
- Death, Stroke, Low Cardiac Output Syndrome, Myocardial Infarction, Renal Failure, Pulmonary Failure
- Keywords
- ischemic preconditioning, cardiac surgery, vascular surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Apr 2011 (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.
Remote ischemic preconditioning (RIPC) occurs when a tissue (ex. heart) becomes less vulnerable to an ischemic insult if a remote tissue (ex. arm) has had previous exposure to a period of ischemia and reperfusion. A beneficial effect of RIPC has been demonstrated in several randomized studies in patients undergoing cardiac and vascular surgery, as well as interventional cardiac procedures such as angioplasty. They have shown improvements in cardiac, renal, neurologic and respiratory function. Most have focused on surrogate outcomes, such as biochemical markers of cardiac and renal function in low-risk patients. No trials have investigated only high-risk patients or been designed to detect clinical outcomes.
This study is a randomized-controlled trial powered to detect clinical events in a high-risk cohort undergoing cardiovascular surgery. Patients will be randomized to RIPC (exposed to cycles of inflation of a blood pressure cuff on the upper arm prior to undergoing surgery) or control (no ischemic stimulus).
The investigators hypothesize this population will demonstrate lower rates of adverse ischemic events. The investigators also intend to sample biochemical markers to better elucidate the mechanism of RIPC and generate hypotheses for future studies and interventions. Post-operatively the investigators will monitor for adverse clinical outcomes including cardiac, renal, pulmonary and neurologic injury.
RIPC is simple, inexpensive and easily reproducible and there have been no reports of adverse consequences. Post-operative ischemic events such as stroke, myocardial infarction, cardiac, renal and respiratory failure affect patient survival and quality of life, and represent a sizeable financial burden to health care. If beneficial effects of RIPC are demonstrated, it will be widely applicable to the entire population of cardiac and vascular patients resulting in a widely-implemented change in practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning stimulus | Experimental | Other: Remote ischemic preconditioning stimulus |
| Control | Placebo comparator | Other: control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing either cardiac or vascular surgical procedures and are deemed to be at increased risk of suffering adverse ischemia-related events (judged by pre-operative evidence of clinical ischemic conditions, pre-operative screening indicating cardiovascular disease or undergoing higher-risk surgery).
Key exclusion criteria (1 listed)
- Will not include emergency cases, patients with known vascular disease (ex. arterial occlusive disease, arterio-venous shunts) or neurologic disease affecting the upper limb and patients unable to give informed consent.
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 |
|---|---|---|
| Remote ischemic preconditioning stimulusThe intervention will consist of 3 cycles of 5 minutes of upper limb ischemia. The RIPC stimulus will be performed using a blood pressure cuff placed on the upper arm inflated above systemic pressure to 200 mmHg for 5 minutes, then deflated for 5 minutes. Ischemia will be assured with the use of a saturation probe on the digit of the involved arm. | Other | Remote ischemic preconditioning stimulus |
| controlThese patients are randomized to placebo, thus they will no undergo the RIPC stimulus. | Other | Control |
Primary outcome
The primary outcome measure will be a composite of clinical MACE (Multiple Adverse Cardiovascular Events), incorporating all-cause mortality, myocardial infarction, stroke, respiratory failure, acute renal failure and low cardiac output syndrome
Time frame: 30 days
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 5 Feb 2016.
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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.
Darrin Payne, MD principal investigator
Queen's University / Kingston General Hospital
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 Remote ischemic preconditioning stimulus in people with Death and Stroke, run by Queen's University 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 1 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 5 Feb 2016. 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. Some participants in this study may receive a placebo. 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?
The primary outcome measure will be a composite of clinical MACE (Multiple Adverse Cardiovascular Events), incorporating all-cause mortality, myocardial infarction, stroke, respiratory failure, acute renal failure and low cardiac output syndrome (time frame: 30 days). 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 5 Feb 2016.