Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Controlled Clinical Trial: Impact of Remote Ischemic Preconditioning Preceding Coronary Artery Bypass Grafting on Inducing Neuroprotection
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.


Options:
A: Arm Label: RIPC; Type: ACTIVE_COMPARATOR; Interventions: Procedure: RIPC, Drug: isoflurane+sufentanil anesthesia | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Control, Drug: isoflurane+sufentanil anesthesia | Intervention Type: PROCEDURE; Name: RIPC; Assigned to Arm(s): RIPC | Intervention Type: PROCEDURE; Name: Control; Assigned to Arm(s): Control | Intervention Type: DRUG; Name: isoflurane+sufentanil anesthesia; Assigned to Arm(s): Control, RIPC
B: Arm Label: Remote ischemic preconditioning; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Remote ischemic preconditioning | Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Procedure: Control | Intervention Type: PROCEDURE; Name: Remote ischemic preconditioning; Assigned to Arm(s): Remote ischemic preconditioning | Intervention Type: PROCEDURE; Name: Control; Assigned to Arm(s): Control
C: Arm Label: Remote ischemic preconditioning; Type: ACTIVE_COMPARATOR; Interventions: Procedure: remote ischemic preconditioning | Arm Label: control; Type: PLACEBO_COMPARATOR; Interventions: Procedure: remote ischemic preconditioning | Intervention Type: PROCEDURE; Name: remote ischemic preconditioning; Assigned to Arm(s): Remote ischemic preconditioning, control
D: Arm Label: ExerciseTr; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise training | Arm Label: Remote ischemic preconditioning group; Type: EXPERIMENTAL; Interventions: Procedure: remote ischemic preconditioning | Arm Label: Control patient group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Exercise training; Assigned to Arm(s): ExerciseTr | Intervention Type: PROCEDURE; Name: remote ischemic preconditioning; Assigned to Arm(s): Remote ischemic preconditioning group

Answer: B