RECRUITINGINTERVENTIONAL

Evaluation and Prediction of the Effect of EECP on HR-NICE Patients

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - Progressive stroke - Diseases with severe damage to other organs - Moderate to severe aortic insufficiency - Dissection aneurysm, aortic aneurysm, cerebral aneurysm - Significant pulmonary hypertension - Various bleeding disorders, bleeding tendencies, or use of anticoagulants, Prothrombin international normalized ratio （INR） \>2.0 - Active phlebitis, venous embolism, venous thrombosis of lower extremity - The presence of infection in the body - Valvular disease, congenital heart disease, cardiomyopathy - Uncontrolled hypertension (\>170/110mmHg) - Uncontrolled arrhythmia - Left heart failure - Pregnancy - Patients with cardiac pacemakers - Patients with arterial clamp after craniocerebral operation - Patients with metal implants, such as metal joints, shrapnel and orbital foreign bodies - History of moderate to severe cognitive impairment or psychiatric disorders - History of malignancy - moyamoya patients - Lower extremity arterial thrombosis Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Exclusion Criteria: * Progressive stroke * Diseases with severe damage to other organs * Moderate to severe aortic insufficiency * Dissection aneurysm, aortic aneurysm, cerebral aneurysm * Significant pulmonary hypertension * Various bleeding disorders, bleeding tendencies, or use of anticoagulants, Prothrombin international normalized ratio （INR） \>2.0 * Active phlebitis, venous embolism, venous thrombosis of lower extremity * The presence of infection in the body * Valvular disease, congenital heart disease, cardiomyopathy * Uncontrolled hypertension (\>170/110mmHg) * Uncontrolled arrhythmia * Left heart failure * Pregnancy * Patients with cardiac pacemakers * Patients with arterial clamp after craniocerebral operation * Patients with metal implants, such as metal joints, shrapnel and orbital foreign bodies * History of moderate to severe cognitive impairment or psychiatric disorders * History of malignancy * moyamoya patients * Lower extremity arterial thrombosis

Treatments Being Tested

DEVICE

real EECP

Real EECP treatment is delivered 45min per day for 14 sessions continuously. The treatment pressure sets at 150 millimeters of mercury.

DEVICE

sham EECP

Sham EECP treatment is delivered 45min per day for 14 sessions continuously. The treatment pressure sets at 75 millimeters of mercury.

Locations (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China