Impact of Remote Ischemic Preconditioning Preceding Coronary Artery Bypass Grafting on Inducing nEuroprotection

NCT02177981 | Completed

• 1 other identifier: 57./3./1.
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary artery disease (CAD) is the leading cause of death worldwide. Patients with severe CAD are often treated with coronary artery bypass grafting (CABG). Novel treatment strategies need to be pursued to respond to the continuous increase in the risk profile of contemporary CABG patients. Surgical myocardial revascularization is commonly performed with the use of cardiopulmonary bypass (CPB). Neurological impairment following CABG may take on the form of a new-onset motor deficit or postoperative cognitive dysfunction. The former is rare, but potentially devastating. Conversely, declines in attention, memory and fine motor skills can frequently be documented. Ischemic preconditioning is a phenomenon of an endogenous protective response to organ ischemia, which is triggered by brief cycles of nonlethal ischemia and reperfusion in tissues known to be more resistant to ischemic insults. In clinical practice remote ischemic preconditioning (RIPC) is achieved by inflicting short periods of ischemia with intermittent restitution of flow to the upper extremity. This intervention has been shown to be effective in the reduction of myocardial injury in cardiac surgical patients. The hypothesis tested in this research proposal is that RIPC will decrease the extent of postoperative neurological injury following CABG. In this research project, 70 patients scheduled for an elective CABG will be recruited at a single center. They will be randomly allocated to either undergo RIPC (intervention arm) or a sham procedure (control arm). Inflating a blood pressure cuff to 200 mmHg for 5 min will induce RIPC, thereby inducing a brief period of ischemia. This will be followed by a 5-minute arm reperfusion. In total, three cycles of arm ischemia and reperfusion will be induced in this fashion. All patients will undergo pre- and post-procedural magnetic resonance imaging (MRI) of the brain, as well as neurocognitive testing. The array of MRI tools that will be used for the quantification of brain injury will include fluid attenuated inversion recovery, diffusion weighted and susceptibility weighted imaging, coupled with resting state functional MRI. The investigators aim to determine whether RIPC can reduce the adverse impact of CPB on neurological outcome as evaluated by MRI detectable brain ischemia and neurocognition.

Conditions

Brain Ischemia; Postoperative Confusion

Keywords

Remote Ischemic Preconditioning; Coronary Artery Bypass Grafting; Diffusion Weighted Magnetic Resonance Imaging; Resting State Functional Magnetic Resonance Imaging; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Composite structural and functional neurological outcome

  New ischemic lesions on brain MRI and postoperative neurocognitive dysfunction

  7 days

Secondary Outcomes (3)

• Brain connectivity profiles

  7 days

• Peri-operative brain injury

  7 days

• Postoperative neurocognitive decline

  7 days

Study Arms (2)

Remote ischemic preconditioning

ACTIVE COMPARATOR

A blood pressure cuff will be placed on the left arm and three cycles of 5 min ischemia followed by 5 min reperfusion will be applied.

Procedure: Remote ischemic preconditioning

Control

SHAM COMPARATOR

The cuff will be placed around the arm but not inflated.

Procedure: Control

Interventions

Remote ischemic preconditioning PROCEDURE

A blood pressure cuff will be placed on the left arm and three cycles of 5 min ischemia followed by 5 min reperfusion will be applied.

Remote ischemic preconditioning

Control PROCEDURE

The cuff will be placed around the arm but not inflated.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with multi-vessel coronary artery disease undergoing primary, elective on-pump CABG
• Written informed consent

You may not qualify if:

• Prior stroke, transient ischemic attack or reversible ischemic neurologic deficit
• Stenosis of the internal carotid artery (\>50%)
• Significant peripheral arterial disease affecting the upper limbs
• Acute coronary syndrome within 30 days prior to surgery
• Inability to provide consent

Sponsors & Collaborators

• University of Zagreb: lead
• Clinical Hospital Centre Zagreb: collaborator

Study Sites (1)

University Hospital Centre Zagreb

Zagreb, City of Zagreb, 10000, Croatia

Location

Related Publications (1)

• Gasparovic H, Kopjar T, Rados M, Anticevic A, Rados M, Malojcic B, Ivancan V, Fabijanic T, Cikes M, Milicic D, Gasparovic V, Biocina B. Impact of remote ischemic preconditioning preceding coronary artery bypass grafting on inducing neuroprotection (RIPCAGE): study protocol for a randomized controlled trial. Trials. 2014 Oct 27;15:414. doi: 10.1186/1745-6215-15-414.

  PMID: 25348157 DERIVED

MeSH Terms

Conditions

Brain Ischemia; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hrvoje Gašparović, MD, PhD

  University of Zagreb School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: June 30, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

CR (1)