Remote Ischemic PreconditioningNCT00546390
Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study
A study testing Blood Pressure Cuff in people with Remote Ischemic Preconditioning and Myocardial Protection, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to compare a treatment called remote ischemic preconditioning (rIP) to no treatment. rIP is a simple treatment that is believed to help patients recover better after heart surgery. This treatment involves applying a large blood pressure cuff to one leg. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Remote Ischemic Preconditioning, Myocardial Protection
- What is being tested?
- Blood Pressure Cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age 18 through 80 years, inclusive
- Scheduled for heart surgery with CPB
Who cannot join
- Females of childbearing potential
- Emergency surgery
- Previous sternotomy
- Myocardial infarction within 48 hours prior to surgery
- Diabetes and/or BMI >35
- Need for Alpha2-agonists perioperatively
- Peripheral Vascular Disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare a treatment called remote ischemic preconditioning (rIP) to no treatment. rIP is a simple treatment that is believed to help patients recover better after heart surgery. This treatment involves applying a large blood pressure cuff to one leg. The blood pressure cuffs will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.
Read the detailed description
Purpose:
- Determine, in a pilot study, if surrogate markers of rIP can be detected in patients presenting for cardiac surgery. Specifically measure the effect of rIP on the expression profile of HSP-70, iNOS, PKC-E, p38 MAPK, PI3K, and sarcolemmal KATP
- Determine if rIP influences the expression of genes known to influence substrate preference and thereby myocardial metabolism in patients undergoing heart surgery. Specifically the expression of HIF-1a, PPAR-a and AMPK
Hypothesis:
We hypothesize that rIP provides myocardial protection in patients presenting for heart surgery and that this protection is defined by a distinct gene expression profile with regards to genes involved in rIP and myocardial metabolism.
Study Design:
This proposal is for a randomized blinded pilot study on the use of rIP in patients requiring heart surgery.
Study Population:
The study will include 100 male and female patients undergoing elective heart surgery with cardiopulmonary bypass (CPB).
Randomization:
Patients will be randomized 1:1 to receive either rIP or no treatment.
Blinding Procedures:
The patient will be blinded as well as those performing the experimental analysis.
Interventions:
Remote Ischemic Preconditioning
rIP will be induced immediately following induction of anesthesia. Four 5 minute cycles of lower unilateral limb ischemia and reperfusion induced tourniquet inflation to 300 mmHg will constitute the preconditioning stimulus.
Blood sample collection/analysis
- Two cardiac biopsies (50 - 200 mg) will be collected pre-bypass and post- bypass and will be analyzed for gene and protein expression.
- Blood samples (4 mL) will be drawn immediately before induction of anesthesia, and at the same times as cardiac tissue samples are harvested and analyzed for gene/protein expression as well as at 1, 24, 48 and 72 hours post surgery. Troponin I and NT-ProBNP will be measured at baseline, 1, 24, 48 and 72 hours after surgery and 3 mL of blood will be collected for these tests. A total of 43 mL of blood will be collected per patient.
- rIP induced changes in leukocyte gene expression will be measured at the aforementioned time points.
Other
ECG assessment on post-operative day 1, 2, and 3.
National Institute of Health stroke scale assessment will be conducted at screening and post operatively prior to hospital discharge.
Each patient will receive a telephone follow-up call at 30 days post operatively to collect adverse events and mortality data.
Experimental Methods:
- qRT-PCR will be used to measure gene expression.
- Immunoblotting will be used to measure protein expression
- Being tested
- Blood Pressure Cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure CuffDevice
The blood pressure cuff will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Preconditioned Group (rIP) | Experimental | A 15-cm sterile blood pressure cuff was placed around the right thigh and connected to the inflating device, and the patient was draped obscuring the visibility of the cuff. Subsequently, the patient was randomly allocated (by opening of an envelope) to RIPC consisting of four 5-min cycles of lower limb ischemia-reperfusion induced by a tourniquet inflated to 300 mmHg Receives: Device: Blood Pressure Cuff |
| No Cuff | No intervention | No rIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Protection Against Ischemic Injury
High-sensitivity cardiac troponin T release as measured by peak hscTnT values and area-under-the-curve.
Measured: 72 hours post operatively
Secondary outcomes (1)
All-cause Death and Cardiovascular Long-term Outcome
Death and re-hospitalization due to any cause including heart and renal failure and new atrial fibrillation
Measured: 6-month cardiovascular outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Remote Ischemic PreconditioningStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry Finegan, University of Alberta
- Investigators
- Barry A Finegan, MB, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546390
- Sponsor's protocol ID
- Protect
- Status last verified
- Oct 2018
- First submitted
- 16 Oct 2007
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lucchinetti E, Bestmann L, Feng J, Freidank H, Clanachan AS, Finegan BA, Zaugg M. Remote ischemic preconditioning applied during isoflurane inhalation provides no benefit to the myocardium of patients undergoing on-pump coronary artery bypass graft surgery: lack of synergy or evidence of antagonism in cardioprotection? Anesthesiology. 2012 Feb;116(2):296-310. doi: 10.1097/ALN.0b013e318242349a.
PubMed 22222469
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT00546390
- Acronym / sponsor ID
- Protect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 18 Oct 2007 (estimated)
- Results
- Posted 15 Feb 2019
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 compare a treatment called remote ischemic preconditioning (rIP) to no treatment. rIP is a simple treatment that is believed to help patients recover better after heart surgery. This treatment involves applying a large blood pressure cuff to one leg. The blood pressure cuffs will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.
Detailed description
Purpose:
- Determine, in a pilot study, if surrogate markers of rIP can be detected in patients presenting for cardiac surgery. Specifically measure the effect of rIP on the expression profile of HSP-70, iNOS, PKC-E, p38 MAPK, PI3K, and sarcolemmal KATP
- Determine if rIP influences the expression of genes known to influence substrate preference and thereby myocardial metabolism in patients undergoing heart surgery. Specifically the expression of HIF-1a, PPAR-a and AMPK
Hypothesis:
We hypothesize that rIP provides myocardial protection in patients presenting for heart surgery and that this protection is defined by a distinct gene expression profile with regards to genes involved in rIP and myocardial metabolism.
Study Design:
This proposal is for a randomized blinded pilot study on the use of rIP in patients requiring heart surgery.
Study Population:
The study will include 100 male and female patients undergoing elective heart surgery with cardiopulmonary bypass (CPB).
Randomization:
Patients will be randomized 1:1 to receive either rIP or no treatment.
Blinding Procedures:
The patient will be blinded as well as those performing the experimental analysis.
Interventions:
Remote Ischemic Preconditioning
rIP will be induced immediately following induction of anesthesia. Four 5 minute cycles of lower unilateral limb ischemia and reperfusion induced tourniquet inflation to 300 mmHg will constitute the preconditioning stimulus.
Blood sample collection/analysis
- Two cardiac biopsies (50 - 200 mg) will be collected pre-bypass and post- bypass and will be analyzed for gene and protein expression.
- Blood samples (4 mL) will be drawn immediately before induction of anesthesia, and at the same times as cardiac tissue samples are harvested and analyzed for gene/protein expression as well as at 1, 24, 48 and 72 hours post surgery. Troponin I and NT-ProBNP will be measured at baseline, 1, 24, 48 and 72 hours after surgery and 3 mL of blood will be collected for these tests. A total of 43 mL of blood will be collected per patient.
- rIP induced changes in leukocyte gene expression will be measured at the aforementioned time points.
Other
ECG assessment on post-operative day 1, 2, and 3.
National Institute of Health stroke scale assessment will be conducted at screening and post operatively prior to hospital discharge.
Each patient will receive a telephone follow-up call at 30 days post operatively to collect adverse events and mortality data.
Experimental Methods:
- qRT-PCR will be used to measure gene expression.
- Immunoblotting will be used to measure protein expression
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Preconditioned Group (rIP) | Experimental | Device: Blood Pressure CuffA 15-cm sterile blood pressure cuff was placed around the right thigh and connected to the inflating device, and the patient was draped obscuring the visibility of the cuff. Subsequently, the patient was randomly allocated (by opening of an envelope) to RIPC consisting of four 5-min cycles of lower limb ischemia-reperfusion induced by a tourniquet inflated to 300 mmHg |
| No Cuff | No intervention | –No rIP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Age 18 through 80 years, inclusive
- Scheduled for heart surgery with CPB
Key exclusion criteria (7 listed)
- Females of childbearing potential
- Emergency surgery
- Previous sternotomy
- Myocardial infarction within 48 hours prior to surgery
- Diabetes and/or BMI >35
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 |
|---|---|---|
| Blood Pressure CuffThe blood pressure cuff will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row. | Device | Ischemic Preconditioned Group (rIP) |
Primary outcome
Myocardial Protection Against Ischemic Injury
Time frame: 72 hours post operatively
High-sensitivity cardiac troponin T release as measured by peak hscTnT values and area-under-the-curve.
1 secondary outcome
All-cause Death and Cardiovascular Long-term Outcome
Time frame: 6-month cardiovascular outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22222469Lucchinetti E, Bestmann L, Feng J, Freidank H, Clanachan AS, Finegan BA, Zaugg M. Remote ischemic preconditioning applied during isoflurane inhalation provides no benefit to the myocardium of patients undergoing on-pump coronary artery bypass graft surgery: lack of synergy or evidence of antagonism in cardioprotection? Anesthesiology. 2012 Feb;116(2):296-310. doi: 10.1097/ALN.0b013e318242349a.
- PubMed linkLink provided by the sponsor.
- 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.
Barry A Finegan, MB principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Pressure Cuff in people with Remote Ischemic Preconditioning and Myocardial Protection, run by University of Alberta 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 3 inclusion and 7 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 15 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Myocardial Protection Against Ischemic Injury (time frame: 72 hours post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00546390, which also lists 1 linked publication.
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 15 Feb 2019.