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Clinical Trials in China / NCT05718622
Recruiting Not applicable

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

NCT05718622 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Phase
Not applicable
Started
2022-11-10
Last updated
2023-02-24

Condition(s) studied

Stroke, Ischemic

Investigational drug(s) / intervention(s)

real EECPsham EECP

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • the change of stroke impact scale (SIS) — baseline(the day before the first EECP treatment); after a course of EECP treatment(14 days)
    Stroke Impact Scale （SIS） is an evaluation of stroke severity affecting daily life and health. It includes 59 items in 8 domains among strength, hand function, mobility, activities of daily living, memory, communication, emotion and social participation. Each item is scored on a scale of 1 - 5 and each domain is scored on a scale of 0 - 100 after conversion. The sum score of 8 domains is set as the total of SIS. A higher score corresponds to a better outcome. In this trial, SIS is evaluated before and after the EECP treatment course, total score of each evaluation is calculated and the change of them is set as the primary outcome measure.

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Xian Jiaotong University Xi'an Shaanxi Recruiting

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Other trials for the same condition

Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2) Recruiting
Antiplatelet Therapy and Endothelial-stabilizing Agents in Cerebral Small Vessel Diseases Recruiting
Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke Recruiting
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET) Recruiting
Effects of an Individual and Family Self-Management of Fall Prevention Program on Balance Ability and Fall-related Self-efficacy Among Chinese Post-Stroke Individuals Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05718622 on ClinicalTrials.gov ↗ ← All trials in China