Effect of Perioperative Ultrasound-guided Remote Ischemic Conditioning on Acute Myocardial Infarction

Summary

Acute myocardial infarction (AMI) is an event of myocardial necrosis caused by myocardial ischemia. Although the incidence and economic burden of AMI has declined in high-income countries, the incidence rate of AMI in China has increased dramatically over the past several decades. Initial medical therapy combined with primary percutaneous coronary intervention (PCI) is currently the most important advance in restoring coronary perfusion. Timely reperfusion therapy may halt the progress of necrosis and preserve viable tissue; however, it can also induce myocardial injury and cause cardiomyocyte death, a phenomenon called myocardial ischemia reperfusion injury (IRI), which can increase final myocardial infarct size by up to 50%. Unfortunately, there is no effective intervention for preventing IRI to date, though an improved understanding of the pathophysiology of IRI has led to the suggestion of several innovative therapeutic strategies with the potential for reducing unintended negative side effects of reperfusion therapy in AMI patients. Whether there is a therapeutic intervention that can effectively and safely reduce myocardial infarct size and cardiac mortality has been intensely explored over the years. Against this backdrop, a phenomenon called remote ischemic conditioning (RIC) has long been discussed as a potential approach to address the above issues. The purpose of present study is to investigate the efficacy of perioperative remote ischemic conditioning delivered at individual timepoints (e.g., pre-, per- and post-PCI) on myocardial injury in patients with AMI.

Conditions

• Acute Myocardial Infarction

Interventions

OTHER

Ultrasound-guided remote ischemic conditioning

Before conducting RIC, Doppler ultrasound was used to measure the total occlusion pressure (TOP) of brachial artery, which was then determined as the cuff inflation pressure during RIC. The RIC program encompasses four main components of (1) three cycles of remote ischemic pre-conditioning which will be delivered right after the eligibility check and informed consent form signature before PCI; (2) one cycle of remote ischemic per-conditioning, which will be delivered during PCI; (3) three cycles of remote ischemic post-conditioning, which will be delivered within 10 min after PCI; and (4) two sessions per day of remote ischemic post-conditioning which will start on post-operative day 1 and last till hospital discharge. The remote ischemic pre- and post-conditioning share the RIC protocol, which comprises three 3 min cycles of RIC with 3 min intervals of reperfusion in between, while only one single 3 min cycle will be delivered for the remote ischemic per-conditioning.

OTHER

Traditional remote ischemic conditioning

The RIC program encompasses four main components of (1)three cycles of remote ischemic pre-conditioning which will be delivered right after the eligibility check and informed consent form signature before PCI; (2)one cycle of remote ischemic per-conditioning, which will be delivered during PCI; (3)three cycles of remote ischemic post-conditioning, which will be delivered within 10 min after PCI; and (4) two sessions per day of remote ischemic post-conditioning which will start on post-operative day 1 and last till hospital discharge. The remote ischemic pre- and post-conditioning share the RIC protocol, which comprises three 3 min cycles of upper limb ischemia on the arm that is opposite to the PCI side with 3 min intervals of reperfusion in between delivered by an automated cuff inflation/deflation device, while only one single 3 min cycle will be delivered for the remote ischemic per-conditioning. The pressure applied during cuff inflation is 20 mmHg above systolic blood pressure.

PROCEDURE

Percutaneous coronary intervention

Percutaneous coronary intervention (PCI) will be performed by a cardiologist or doctor who specializes in the heart to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque. PCI requires cardiac catheterization, which is the insertion of a catheter tube, and live x rays helping to guide the catheter into the heart to inject special contrast dye that will highlight the blockage. To open a blocked artery, another catheter will be inserted over a guidewire, a balloon will be inflated at the tip of that catheter, and a small mesh tube called a stent may be put in the artery to help keep the artery open. After PCI, the catheters will be removed, the opening on the wrist or groin will be closed and bandaged.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Principal Investigators

• Xiao Lu, M.D. · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• China

Study Locations