Evaluating the effects of EECP treatment on patients with mild strokes

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

This study is testing if a special treatment called EECP can help people who have had mild strokes feel better and prevent further problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT05718622 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of Enhanced External Counterpulsation (EECP) on patients who have experienced high-risk non-disabling ischemic cerebrovascular events (HR-NICE). The study employs a randomized, double-blind, controlled design, where participants are assigned to receive either real or sham EECP treatment. The primary outcome measure is the improvement in symptoms as assessed by the Stroke Impact Scale, alongside comprehensive evaluations using multi-model magnetic resonance imaging and genetic testing to understand the underlying neural and peripheral abnormalities. The goal is to provide objective evidence for the efficacy of EECP in preventing further neurological deterioration in these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have experienced a mild ischemic stroke and have confirmed moderate to severe stenosis in relevant arteries.

Not a fit: Patients with progressive strokes or severe damage to other organs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of severe strokes in patients with HR-NICE.

How similar studies have performed: While EECP has been established for circulatory support, this specific application in HR-NICE patients is novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Xi'an, Shaanxi

• First Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Wanghuan Dun, doctor

Conditions Stroke, Ischemic