Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03363958
Other study ID # RIPC Trial
Secondary ID
Status Recruiting
Phase Phase 2
First received November 30, 2017
Last updated November 30, 2017
Start date January 1, 2014
Est. completion date January 1, 2020

Study information

Verified date November 2017
Source Medinet Heart Centre
Contact Jakub S. Marczak, M.D.
Phone 0048883774566
Email marczak@space.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the addition of remote ischemic preconditioning and postconditioning to standard myocardial protection protocol in patients submitted to off - pump coronary artery bypass grafting in a prospective, 1:1 randomized, double blind fashion. An interventional group will receive remote ischemic preconditioning 24-hours before OP-CABG, immediately before surgery and within 60 minutes following surgery by means of lower limb ischemia achieved by pressure cuff inflation, whereas control group will receive sham procedure perioperatively.


Description:

In a prospective, 1:1 randomized and double blind fashion, the study will evaluate the impact of remote ischemic preconditioning, both immediate and second window of protection (24 hours and immediately before surgery) with remote ischemic postconditiong on operative outcomes in patients submitted to coronary artery bypass grafting without use of extracorporeal circulation.

Remote ischemic conditioning was found to provide protection against necrosis and apoptosis due to ischemia and reperfusion injury, a phenomenon observed during coronary artery bypass grafting. That in turn was associated with poor postoperative outcomes, predominantly poor survival.

Remote ischemic preconditioning will be provided by repeated lower leg ischemia and reperfusion with pressure cuff inflation for five minutes and deflation for five minutes in three consecutive cycles. Remote ischemic preconditioning will be performed 24 hours before CABG and immediately before surgery. Remote ischemic postconditioning will be performed within 60 minutes following the last coronary artery bypass graft completion and the restoration of coronary blood flow.

The study will assess clinical endpoints such as postoperative acute myocardial infarction (type 5 MI), postoperative mortality, postoperative renal failure and laboratory outcomes such as postoperative serial measurements of troponin T release or glomerular filtration rate as secondary outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date January 1, 2020
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

Patients qualified to coronary artery bypass grafting according to ESC/EACTS Guidelines of myocardial revascularization, suffering from:

- Multivessel coronary artery disease amenable for surgical treatment

- Negative history of previous cardiac or vascular surgery in childhood and afterwards.

- Negative history of active neoplastic disease, neither past medical history of oncological treatment

- Patients with non insulin dependent diabetes mellitus treated chronically with oral derivatives of sulfonylourea such as but not limited to: glibenclamide.

Exclusion Criteria:

Patients suffering from acute insuficiency of any organ/ system and those suffering from end stage organ failure such as:

- Chronic renal disease - KDOQI stage = 3;

- Chronic renal failure class A by Child - Pugh'a;

- Chronic respiratory failure (type I and II according to Campbell et al. and type I according to Wood et al.);

- Chronic intermittent claudication class 2A according to Fontaine;

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Remote Ischemic Preconditioning with Postconditioning
Three cycles of 5 minutes of ischemia and 5 minutes of reperfusion of lower leg 24 hours, immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively.
Sham RIPC procedure
Three cycles of 5 minutes of inflation and 5 minutes of deflation of artificial lower leg immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively.

Locations

Country Name City State
Poland Medinet Heart Centre Nowa Sol Lubuskie

Sponsors (1)

Lead Sponsor Collaborator
Medinet Heart Centre

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Marczak J, Nowicki R, Kulbacka J, Saczko J. Is remote ischaemic preconditioning of benefit to patients undergoing cardiac surgery? Interact Cardiovasc Thorac Surg. 2012 May;14(5):634-9. doi: 10.1093/icvts/ivr123. Epub 2012 Jan 26. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative myocardial necrosis Serial mesurements of High - Sensitive Troponin T release 72 hours postoperatively
Primary Postoperative kidney injury Serial measurements of estimated glomerular filtration rate by creatinine 7 days postoperatively
Secondary Perioperative mortality 30-day all cause mortality 30 days postoperatively
Secondary Perioperative myocardial infarction 30-day myocardial infarction 30 days postoperatively
Secondary Postoperative Acute Kidney Injury Prevalence of acute kidney injury according to Society of Thoracic Surgeons definitions of outcomes. 30 days
See also
  Status Clinical Trial Phase
Recruiting NCT03235323 - Efficacy of External CounterPulsation for Postoperative Coronary Artery Bypass Grafting Patients N/A
Completed NCT05036044 - Stroke and Carotid-Cerebral Vascular Disease After CABG
Recruiting NCT05010460 - Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting Phase 2
Completed NCT03622671 - Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting N/A
Completed NCT00400790 - Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane N/A
Not yet recruiting NCT03275220 - Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Completed NCT00489827 - Glutamate for Metabolic Intervention in Coronary Surgery Phase 3
Completed NCT04591119 - Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery N/A
Active, not recruiting NCT03908593 - Proton Pump Inhibitor Preventing Upper Gastrointestinal Injury In Patients On Dual Antiplatelet Therapy After CABG Phase 4
Recruiting NCT03774342 - The Influence of Cognitive Decline on Quality of Life After Coronary Bypass
Enrolling by invitation NCT03999398 - Short and Long-term Results of PCI in no Touch Vein-graft.
Recruiting NCT05414331 - WithDRawal Impact Of Postoperative Beta-Blocker N/A
Completed NCT02981680 - Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery N/A
Completed NCT00600704 - Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery N/A
Completed NCT06013605 - Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft N/A
Active, not recruiting NCT02731794 - On-pump Beating Coronary Artery Bypass Grafting by Ventricular Assist Phase 4
Completed NCT02722213 - Mindfulness & Stress Management Study for Cardiac Patients N/A
Completed NCT01285271 - A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon Phase 3
Completed NCT00823082 - Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass Phase 2

External Links