The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery (RIPC-Angina)

September 3, 2017 updated by: Won Ho Kim, MD, Seoul National University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Peripheral vascular disease involving upper or lower extremity
  • Orthopedic surgery which uses the tourniquet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RIPC group
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
Procedure: Remote ischemic preconditioning
three cycles of ischemia (5 min) / reperfusion (5 min) of available upper or lower limb with an automated machine using blood pressure cuff
Sham Comparator: Control group
No remote ischemic conditioning, but blood pressure cuff applied to the upper or lower limb available
Procedure: Sham control
The patients had the same pneumatic cuff around the upper arm and similar maneuvers were performed, but pressure was not applied to the cuff.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Troponin-I
Time Frame: postoperative day one
postoperative day one

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time Frame: immediate postoperative
immediate postoperative
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time Frame: postoperative day one
postoperative day one
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time Frame: postoperative day two
postoperative day two
Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)
Time Frame: postoperative day four
postoperative day four
Acute kidney injury
Time Frame: postoperative 48 hours
Acute kidney injury determined by AKIN criteria
postoperative 48 hours
ST-II segment analysis by Electrocardiography
Time Frame: every 30 minutes during surgery
every 30 minutes during surgery
Oxygenation index (PaO2/FiO2)
Time Frame: 5 minutes after anesthesia induction
5 minutes after anesthesia induction
Oxygenation index (PaO2/FiO2)
Time Frame: 5 minutes before the end of surgery
5 minutes before the end of surgery
Oxygenation index (PaO2/FiO2)
Time Frame: 20 minutes after the end of surgery
(at PACU)
20 minutes after the end of surgery
Oxygenation index (PaO2/FiO2)
Time Frame: postoperative day one
postoperative day one
length of hospital stay
Time Frame: up to 24 week
length of hospital stay
up to 24 week
length of ICU stay
Time Frame: up to 24 week
length of ICU stay
up to 24 week
Postoperative wound infection
Time Frame: up to 24 week
Postoperative wound infection
up to 24 week
Postoperative incidence of pneumonia
Time Frame: up to 24 week
Postoperative incidence of pneumonia
up to 24 week
Postoperative incidence of myocardial ischemic event
Time Frame: up to 24 week
Postoperative incidence of myocardial ischemic event
up to 24 week
Troponin-I
Time Frame: immediate postoperative
immediate postoperative
Troponin-I
Time Frame: Postoperative day two
Postoperative day two
Troponin-I
Time Frame: Postoperative day four
Postoperative day four
Creatinine
Time Frame: Immediate Postoperative
Immediate Postoperative
Creatinine
Time Frame: Postoperative day one
Postoperative day one
Creatinine
Time Frame: Postoperative day two
Postoperative day two
Creatinine
Time Frame: Postoperative day four
Postoperative day four

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1604-079-754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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