Angina PectorisRIPC-AnginaNCT02808936
The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery
A study testing Remote ischemic preconditioning in people with Angina Pectoris and Myocardial Infarction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators attempt to investigate the organ protective effect of remote ischemic conditioning in patients undergoing non-cardiac surgery with history of ischemic heart disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Angina Pectoris, Myocardial Infarction
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Jun 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients who undergo orthopedic surgery with duration of longer than one hour
- Patients with a history of ischemic heart disease (stable or unstable angina, myocardial infarction)
- American Society of Anesthesiology (ASA) Physical Status Classification of 1, 2, or 3
Who cannot join
- Peripheral vascular disease involving upper or lower extremity
- Orthopedic surgery which uses the tourniquet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery - a Randomized Controlled Trial
The investigators attempt to investigate the organ protective effect of remote ischemic conditioning in patients undergoing non-cardiac surgery with history of ischemic heart disease.
Read the detailed description
When adult patients with ischemic heart disease undergo non-cardiac surgery, perioperative ischemic complication may occur. These morbidity results in poor clinical outcomes. The incidence of perioperative myocardial ischemic event has been reported to be up to 19.7%. Remote ischemic preconditioning (RIPC) is a concept that a brief ischemic reperfusion of upper or lower extremity can transfer protection to the other vital organs from sustained ischemic reperfusion injury. Although RIPC is extensively studied in high risk cardiovascular surgery, it has not been tested in a non-cardiac surgery patients with a history of ischemic heart disease. Major organ injury including heart, lung and kidney will be evaluated in this randomized controlled trial.
- Conditions
- Angina Pectoris, Myocardial Infarction
- Being tested
- Remote ischemic preconditioning, Sham control
- Keywords
- remote ischemic conditioning, orthopedic surgery, ischemic heart disease
- Medical subject headings
- Angina Pectoris, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
three cycles of ischemia (5 min) / reperfusion (5 min) of available upper or lower limb with an automated machine using blood pressure cuff
Sham controlProcedure or surgery
The patients had the same pneumatic cuff around the upper arm and similar maneuvers were performed, but pressure was not applied to the cuff.
| Study group | Role | What they receive |
|---|---|---|
| RIPC group | Experimental | remote ischemic conditioning group with three cycles of ischemia (5 min) / reperfusion (5 min) of upper or lower limb available with automated RIPC machine using blood pressure cuff Receives: Procedure: Remote ischemic preconditioning |
| Control group | Sham comparator | No remote ischemic conditioning, but blood pressure cuff applied to the upper or lower limb available Receives: Procedure: Sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin-I
Measured: postoperative day one
Secondary outcomes (22)
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Measured: immediate postoperative
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Measured: postoperative day one
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Measured: postoperative day two
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Measured: postoperative day four
Acute kidney injury
Acute kidney injury determined by AKIN criteria
Measured: postoperative 48 hours
ST-II segment analysis by Electrocardiography
Measured: every 30 minutes during surgery
Oxygenation index (PaO2/FiO2)
Measured: 5 minutes after anesthesia induction
Oxygenation index (PaO2/FiO2)
Measured: 5 minutes before the end of surgery
Oxygenation index (PaO2/FiO2)
(at PACU)
Measured: 20 minutes after the end of surgery
Oxygenation index (PaO2/FiO2)
Measured: postoperative day one
length of hospital stay
length of hospital stay
Measured: up to 24 week
length of ICU stay
length of ICU stay
Measured: up to 24 week
Postoperative wound infection
Postoperative wound infection
Measured: up to 24 week
Postoperative incidence of pneumonia
Postoperative incidence of pneumonia
Measured: up to 24 week
Postoperative incidence of myocardial ischemic event
Postoperative incidence of myocardial ischemic event
Measured: up to 24 week
Troponin-I
Measured: immediate postoperative
Troponin-I
Measured: Postoperative day two
Troponin-I
Measured: Postoperative day four
Creatinine
Measured: Immediate Postoperative
Creatinine
Measured: Postoperative day one
Creatinine
Measured: Postoperative day two
Creatinine
Measured: Postoperative day four
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808936
- Sponsor's protocol ID
- 1604-079-754
- Acronym
- RIPC-Angina
- Status last verified
- Sep 2017
- First submitted
- 14 Jun 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02808936
- Acronym / sponsor ID
- RIPC-Angina / 1604-079-754
- Conditions
- Angina Pectoris, Myocardial Infarction
- Keywords
- remote ischemic conditioning, orthopedic surgery, ischemic heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators attempt to investigate the organ protective effect of remote ischemic conditioning in patients undergoing non-cardiac surgery with history of ischemic heart disease.
Detailed description
When adult patients with ischemic heart disease undergo non-cardiac surgery, perioperative ischemic complication may occur. These morbidity results in poor clinical outcomes. The incidence of perioperative myocardial ischemic event has been reported to be up to 19.7%. Remote ischemic preconditioning (RIPC) is a concept that a brief ischemic reperfusion of upper or lower extremity can transfer protection to the other vital organs from sustained ischemic reperfusion injury. Although RIPC is extensively studied in high risk cardiovascular surgery, it has not been tested in a non-cardiac surgery patients with a history of ischemic heart disease. Major organ injury including heart, lung and kidney will be evaluated in this randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC group | Experimental | Procedure: Remote ischemic preconditioningremote ischemic conditioning group with three cycles of ischemia (5 min) / reperfusion (5 min) of upper or lower limb available with automated RIPC machine using blood pressure cuff |
| Control group | Sham comparator | Procedure: Sham controlNo remote ischemic conditioning, but blood pressure cuff applied to the upper or lower limb available |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults patients who undergo orthopedic surgery with duration of longer than one hour
- Patients with a history of ischemic heart disease (stable or unstable angina, myocardial infarction)
- American Society of Anesthesiology (ASA) Physical Status Classification of 1, 2, or 3
Key exclusion criteria (2 listed)
- Peripheral vascular disease involving upper or lower extremity
- Orthopedic surgery which uses the tourniquet
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 preconditioningthree cycles of ischemia (5 min) / reperfusion (5 min) of available upper or lower limb with an automated machine using blood pressure cuff | Procedure or surgery | RIPC group |
| Sham controlThe patients had the same pneumatic cuff around the upper arm and similar maneuvers were performed, but pressure was not applied to the cuff. | Procedure or surgery | Control group |
Primary outcome
Troponin-I
Time frame: postoperative day one
22 secondary outcomes
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time frame: immediate postoperative
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time frame: postoperative day one
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time frame: postoperative day two
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time frame: postoperative day four
Acute kidney injury
Time frame: postoperative 48 hours
ST-II segment analysis by Electrocardiography
Time frame: every 30 minutes during surgery
Oxygenation index (PaO2/FiO2)
Time frame: 5 minutes after anesthesia induction
Oxygenation index (PaO2/FiO2)
Time frame: 5 minutes before the end of surgery
Oxygenation index (PaO2/FiO2)
Time frame: 20 minutes after the end of surgery
Oxygenation index (PaO2/FiO2)
Time frame: postoperative day one
length of hospital stay
Time frame: up to 24 week
length of ICU stay
Time frame: up to 24 week
Postoperative wound infection
Time frame: up to 24 week
Postoperative incidence of pneumonia
Time frame: up to 24 week
Postoperative incidence of myocardial ischemic event
Time frame: up to 24 week
Troponin-I
Time frame: immediate postoperative
Troponin-I
Time frame: Postoperative day two
Troponin-I
Time frame: Postoperative day four
Creatinine
Time frame: Immediate Postoperative
Creatinine
Time frame: Postoperative day one
Creatinine
Time frame: Postoperative day two
Creatinine
Time frame: Postoperative day four
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 7 Sep 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning in people with Angina Pectoris and Myocardial Infarction, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 7 Sep 2017. 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 South Korea. 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.
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?
Troponin-I (time frame: postoperative day one). 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 7 Sep 2017.