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Recruiting NCT05718622

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

Conditions: Stroke, Ischemic

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Location: China

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 Criteria

Inclusion Criteria:In accordance with the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018Patients who have had a clinically significant ischemic stroke for the first time and are currently stableUnilateral internal carotid artery or middle cerebral artery was confirmed for the first time as moderate to severe stenosis (≥50%) or occlusion on DSA examination.Did not receive surgical treatment such as balloon dilationNational Institute of Health stroke scale (NIHSS) score ≤3The clinical data is completed and be able to consistently complete the studyAge 18-80, education level≥ 6 years and agree to sign informed consentExclusion Criteria:Progressive strokeDiseases with severe damage to other organsModerate to severe aortic insufficiencyDissection aneurysm, aortic aneurysm, cerebral aneurysmSignificant pulmonary hypertensionVarious bleeding disorders, bleeding tendencies, or use of anticoagulants, INR >2.0Active phlebitis, venous embolism, venous thrombosis of lower extremityThe presence of infection in the bodyValvular disease, congenital heart disease, cardiomyopathyUncontrolled hypertension (>170/110mmHg)Uncontrolled arrhythmiaLeft heart failurePregnancyPatients with cardiac pacemakersPatients with arterial clamp after craniocerebral operationPatients with metal implants, such as metal joints, shrapnel and orbital foreign bodiesHistory of moderate to severe cognitive impairment or psychiatric disordersHistory of malignancymoyamoya patientsLower extremity arterial thrombosis

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Source: ClinicalTrials.gov (NCT05718622). StuddyBuddy aggregates publicly available trial information.