- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01903161
Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury (RIPC)
Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury in Patients Undergoing Cardiac Valve Replacement Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ischemic preconditioning is one of the strategies that can reduce perioperative myocardial injury. It is a concept that briefly induced ischemia and reperfusion before the myocardial injury can reduce the myocardial injury. But it is difficult to apply ischemic preconditioning in operative field, because cross-clamping of aorta or coronary artery is difficult and invasive. Afterward concept of remote ischemic preconditioning(RIPC) has introduced that ischemia of remote organs like kidneys, skeletal muscles can reduce distant myocardial injury.
It is known that myocardial protective effect of ischemic preconditioning have biphasic pattern. Early protective effect wanes after a few hours, then recurs after 24-48 hours, and can persist for up to 3-4 days. It is called second window of preconditioning or delayed ischemic preconditioning. Delayed ischemic preconditioning is similar to early ischemic preconditioning in mechanism but it is different that it produces protein that can mediate myocardial protection effect.
Unlike ischemic preconditioning, it is little known about delayed effect of RIPC. RIPC can be done by applying compression cuff on upper or lower extremities and it is noninvasive and easy to deliver compared to ischemic preconditioning that is done by aorta or coronary artery clamping.
Delayed ischemic preconditioning is performed one day before the surgery, and it is safe and easy to apply RIPC in a clinical setting. And in this study investigators are going to evaluate cardioprotective effect of delayed RIPC. Myocardial injury can be predicted by elevation of cardiac enzyme. Investigators are going to perform RIPC one day before the valve replacement surgery and compare troponin I with control group to assess cardioprotective effect of delayed RIPC.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 - 80 years of adult patient undergoing cardiac valve surgery
Exclusion Criteria:
- Patient who did not agree to the study
- Emergency operation
- Using inotropics, mechanical assisting device
- Severe liver disease (>Child class II )
- Severe renal disease (Renal replacement therapy)
- left ventricular ejection fraction < 30%
- Co-operation of major surgery (Carotid endarterectomy )
- Oral hypoglycemic agent (Sulfonylurea, Glibenclamide)
- peripheral vascular disease affecting upper extremity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: delayed remote ischemic preconditioning
applying pneumatic cuff on upper extremity (5 minutes cycles of limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times)
|
In the delayed RIPC group, RIPC is performed 24-48 hr before surgery by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.
|
Placebo Comparator: control
All the procedures were the same in the control group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
|
In the control group, all the procedures were the same with delayed RIPC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Troponin I change
Time Frame: before induction of anesthesia, postoperative 1, 6, 12, 24, 48, 72 hours
|
before induction of anesthesia, postoperative 1, 6, 12, 24, 48, 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum creatinine changes
Time Frame: before induction of anesthesia, postoperative 1, 3, 5 days
|
before induction of anesthesia, postoperative 1, 3, 5 days
|
Collaborators and Investigators
Investigators
- Study Director: Deok Man Hong, M.D., Ph. D., Seoul National University Hospital
- Study Director: Tae Kyong Kim, M.D., Seoul National University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- delayed RIPC
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.
Clinical Trials on Myocardial Injury
-
Damascus UniversityCompletedMyocardial Injury | Cardiac Surgery | Myocardial ProtectionSyrian Arab Republic
-
University Hospital Schleswig-HolsteinAbbott; Department of Anaesthesiology and Intensive Care MedicineCompletedMyocardial InjuryGermany
-
Mahidol UniversityCompletedMyocardial InjuryThailand
-
Rigshospitalet, DenmarkCompletedMyocardial InjuryDenmark
-
Minneapolis Veterans Affairs Medical CenterActive, not recruitingMyocardial InjuryUnited States
-
Zealand University HospitalCompleted
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedMyocardial InjuryNorway
-
Beijing Friendship HospitalUnknownReperfusion Injury, Myocardial | STEMI - ST Elevation Myocardial InfarctionChina
-
Baskent UniversityUnknown
-
Thomas EngstromActive, not recruitingST Elevation Myocardial Infarction | Myocardial Injury | Inflammatory Response | Myocardial Reperfusion InjuryDenmark
Clinical Trials on delayed remote ischemic preconditioning
-
Tartu University HospitalCompletedAtherosclerosis | Stable Angina | Peripheral Artery Disease | Contrast-induced NephropathyEstonia
-
St. Francis Hospital, New YorkTerminatedCoronary Artery DiseaseUnited States
-
Capital Medical UniversityPeking University First HospitalCompletedCerebral Small Vessel DiseaseChina
-
Azienda Ospedaliera Città della Salute e della...CompletedAcute Kidney InjurySpain, France, Italy
-
Medical University of LodzCompletedRemote Ischemic Preconditioning | Contrast Induced - Acute Kidney InjuryPoland
-
Ulsan University HospitalCompletedContrast Induced Acute Kidney InjuryKorea, Republic of
-
Università Vita-Salute San RaffaeleRecruitingMyocardial Ischemia | SurgeryItaly, Russian Federation, Serbia
-
Institut für Pharmakologie und Präventive MedizinWithdrawnEffectivity of RIPC in Outcomes of TAVI ProcedureGermany
-
Xijing HospitalUnknownCardiac Surgery PatientsChina