Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Remote Ischemic Preconditioning on Subclinical Myocardial Injury in Major Abdominal Surgery: a Randomised Controlled Trial
Brief Summary: Recent data suggests that subclinical myocardial injury occurs in patients undergoing major abdominal surgery, and the degree of damage is proportionally linked to morbidity and mortality in the short and medium terms. Therefore, new methods of limiting myocardial damage are urgently needed.

Ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion stimulus gives a protective effect to further ischemic insults. In remote ischemic preconditioning (RIPC), this initial stimulus is carried out away from the region of interest, normally a limb. In meta-analysed syntheses the effect size of RIPC in reducing cardiac damage during bypass grafting, as characterised by troponin release, seems to be about 35%.

The PRIME Study will assess the value of RIPC in reducing subclinical myocardial injury in patients undergoing major abdominal surgery. Post-operative troponin release will be used as a surrogate marker of myocardial damage. There is no good data on which to build a reliable sample size calculation, therefore we estimated samples sizes using supplementary data from the recent VISION study. The investigators intend to build a clinically powered study from the results of this study.

Study design will be by single-centre single-blind randomised control trial. Allocation will be 1:1. All treatments will be carried after induction of anaesthesia, prior to surgery. In the RIPC-treatment group, a blood pressure cuff inflated on an upper limb to 200mmHg for 5 minutes, and then deflated for 5 minutes, repeated in three cycles. In the control group, the blood pressure cuff will not be inflated, but the patient will remain under anaesthesia for the same amount of time.

Primary endpoint will be peak post-operative 5th generation hs-TnT (highly sensitive Troponin-T, ng/ml). Secondary endpoint will be hs-TnT area-under-the-curve, major adverse cardiovascular events, serious surgical complications, non-cardiovascular death, quality of life, and length of stay.


Options:
A: Arm Label: RIPC intervention; Type: EXPERIMENTAL; Interventions: Other: remote ischemic preconditioning | Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Other: Control | Intervention Type: OTHER; Name: remote ischemic preconditioning; Assigned to Arm(s): RIPC intervention | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control
B: Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Remote ischaemic preconditioning | Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Procedure: Control | Intervention Type: PROCEDURE; Name: Remote ischaemic preconditioning; Assigned to Arm(s): Intervention | Intervention Type: PROCEDURE; Name: Control; Assigned to Arm(s): Control
C: Arm Label: RIPC group; Type: EXPERIMENTAL; Interventions: Procedure: Remote ischemic preconditioning, Procedure: Carotid Artery Stenting | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Carotid Artery Stenting | Arm Label: Sham RIPC group; Type: SHAM_COMPARATOR; Interventions: Procedure: Sham remote ischemic preconditioning, Procedure: Carotid Artery Stenting | Intervention Type: PROCEDURE; Name: Remote ischemic preconditioning; Assigned to Arm(s): RIPC group | Intervention Type: PROCEDURE; Name: Sham remote ischemic preconditioning; Assigned to Arm(s): Sham RIPC group | Intervention Type: PROCEDURE; Name: Carotid Artery Stenting; Assigned to Arm(s): Control group, RIPC group, Sham RIPC group
D: Arm Label: Sham; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Control | Arm Label: RIPC; Type: EXPERIMENTAL; Interventions: Procedure: Preconditioning | Intervention Type: PROCEDURE; Name: Preconditioning; Assigned to Arm(s): RIPC | Intervention Type: PROCEDURE; Name: Control; Assigned to Arm(s): Sham

Answer: B