A Neuroimaging Prediction Study Based on Multi-model Magnetic Resonance Imaging Technology to Evaluate the Therapeutic Effect of EECP on HR-NICE Patients

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Stroke is one of the most threatening causes of mortality and disability worldwide. High risk non-disabling ischemic cerebrovascular events (HR-NICE), defined by mild stroke complicating with greater than 50% atherosclerotic stenosis in intracranial or extracranial arteries, is more likely to develop severe stroke in future. Currently, the clinical treatment for HR-NICE patients is limited to dual antiplatelet therapy or endovascular treatment, both of which are taken controversially due to the side effect or high risk. Enhanced external counterpulsation (EECP) is an established non-invasive treatment for circulatory support. By inflating repeatedly and sequentially from calves to hips in the early diastolic phase of every cardiac cycle, EECP has been demonstrated to increase the shear stress of blood vessels, enhance the collateral circulation and improve brain perfusion in patients with stroke. However, few studies have devoted exclusively to patients with HR-NICE. It is not clear whether EECP can improve the clinical performance or reduce the rate of recurrent stroke in 90 days. In this trial, HR-NICE patients will be divided into two groups according to true or sham EECP treatment. Based on multi-model magnetic resonance imaging, the investigators explore the central neural characteristic before and after EECP treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• In accordance with the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018

• Patients who have had a clinically significant ischemic stroke for the first time and are currently stable

• Unilateral internal carotid artery or middle cerebral artery was confirmed for the first time as moderate to severe stenosis (≥50%) or occlusion on digital subtraction angiography examination (DSA).

• Did not receive surgical treatment such as balloon dilation

• National Institute of Health stroke scale (NIHSS) score ≤3

• The clinical data is completed and be able to consistently complete the study

• Age 18-80, education level≥ 6 years and agree to sign informed consent

Locations
Other Locations
China
First Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
Contact Information
Primary
Wanghuan Dun, doctor
wanghuandun@163.com
0086-18092706568
Time Frame
Start Date: 2022-11-10
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 100
Treatments
Experimental: real EECP
Sham_comparator: sham EECP
No_intervention: Health Control
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital Xi'an Jiaotong University

This content was sourced from clinicaltrials.gov