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

  • STATUS
    Recruiting
  • days left to enroll
    24
  • participants needed
    60
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Updated on 19 November 2021

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.

Description

RIC refers to a cardio-protective effect induced by non-invasively applying cycles of physiological ischemia and reperfusion to remote body parts, e.g., through application of a blood pressure cuff or similar device to a remote limb. The actual molecular biological mechanisms underlying RIC may be attributed to a neuro-hormonal pathway conveying a cardio-protective signal from a local limb to the remote heart. The safety of RIC delivered at a single time point (e.g., pre-, per- or post-PCI) in AMI patients has been well established in a number of clinical trials. However, the RIC's cardio-protective effects remain under debate, especially for RIC programs delivered at individual timepoints during operative period (pre-, per- and post-PCI). Besides, in these trials, the cuff compression pressure of RIC protocol is mostly 200mmHg or 20-50mmHg above systolic pressure. Peripheral vascular ischemia effects of upper limbs are different under different pressure conditions. However, no study has been conducted to investigate the clinical effects of RIC training under different pressure conditions. In the present study, ultrasound is used to determine the brachial artery total occlusion pressure (TOP), which is regarded as optimal pressure of flow restriction in ischemic exercise training. And patients in the ultrasound-guided RIC group will receive RIC applying TOP as cuff compression pressure, while compression pressure applied in traditional RIC group patients is 20mmHg above systolic pressure. The purpose of present study is to investigate the effect of perioperative RIC delivered across the full disease cycle, and compare the effects of ultrasound-guided RIC protocol and traditional RIC protocol on cardiac enzyme infarct size, cardiac function, cardiopulmonary endurance and quality of life in patients with AMI.

Details
Condition Acute Myocardial Infarction
Treatment Percutaneous coronary intervention, Ultrasound-guided remote ischemic conditioning, Traditional remote ischemic conditioning
Clinical Study IdentifierNCT05044806
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on19 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Newly developed ST segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (non-STEMI) according to clinical symptoms, ECG and laboratory confirmation
Patients aged 18-80 yr
Scheduled for PCI
With normal cognitive function indicated by MMSE score >16 and able to cooperate with intervention
Agreed to participate and signed the consent form

Exclusion Criteria

Previous STEMI or non-STEMI
Previous coronary artery bypass grafting (CABG)
Developed thrombolysis within the last 30 days
Cardiogenic shock history
Persistent atrial fibrillation history
Severe complications (e.g. ventricular septal rupture, free wall rupture or acute severe mitral regurgitation) warrant surgical interventions
Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
With peripheral neuropathy, peripheral artery disease, superficial thrombophlebitis or deep vein thrombosis
Other severe systemic diseases
Participated in other trials previously
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