Actively Recruiting
Evaluation and Prediction of the Effect of EECP on HR-NICE Patients
Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2023-02-24
100
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation and Prediction of the Effect of EECP on HR-NICE Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- In line with Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018
- First clinically significant ischemic stroke and currently stable
- Moderate to severe (≥50%) or occlusion in unilateral internal carotid artery or middle cerebral artery confirmed by digital subtraction angiography
- No prior surgical treatments like balloon dilation
- National Institute of Health stroke scale (NIHSS) score of 3 or less
- Complete clinical data and ability to comply with study procedures
- Age between 18 and 80 years
- Education level of at least 6 years
- Willingness to sign informed consent
You will not qualify if you...
- Progressive stroke
- Severe damage to other organs
- Moderate to severe aortic insufficiency
- Dissection aneurysm, aortic aneurysm, or cerebral aneurysm
- Significant pulmonary hypertension
- Bleeding disorders, bleeding tendencies, or use of anticoagulants with INR >2.0
- Active phlebitis, venous embolism, or thrombosis in lower extremities
- Current infection
- Valvular disease, congenital heart disease, or cardiomyopathy
- Uncontrolled hypertension (>170/110 mmHg)
- Uncontrolled arrhythmia
- Left heart failure
- Pregnancy
- Cardiac pacemaker
- Arterial clamp after brain surgery
- Metal implants such as metal joints, shrapnel, or orbital foreign bodies
- History of moderate to severe cognitive impairment or psychiatric disorders
- History of cancer
- Moyamoya disease
- Lower extremity arterial thrombosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
Research Team
W
Wanghuan Dun, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here