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Tests a pressure-wave device in people with ischemic stroke risk

Compares a real and a sham external counterpulsation device in people with high-risk stroke.

Key facts

Who runs it
First Affiliated Hospital Xi'an Jiaotong University
Where
Xi'an, ChinaSee the site
Trial code
Registry title
Evaluation and Prediction of the Effect of EECP on HR-NICE Patients
Status
Recruiting
People taking part
100 people, planned
Started
10 Nov 2022
Expected to end
30 Nov 2027
Type of study
Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • real EECP
  • sham EECP
Record updated
24 February 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-80 who had a first mild ischemic stroke, are now stable, and have a narrowed or blocked carotid or middle cerebral artery on one side.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
First clinically significant ischemic stroke, now stable, with NIHSS score 3 or lower. One internal carotid or middle cerebral artery narrowed by 50% or more, or blocked, seen for the first time on DSA.
Earlier treatment
No surgical treatment such as balloon dilation.

Main reasons for not taking part

  • Progressive stroke
  • Bleeding disorders, bleeding tendency, anticoagulant use, or INR above 2.0
  • Heart problems such as valve disease, heart failure, uncontrolled arrhythmia, or a pacemaker
  • Uncontrolled high blood pressure (above 170/110mmHg)
  • Pregnancy, history of cancer, or metal implants

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients with metal implants, such as metal joints, shrapnel and orbital foreign bodies
  • Progressive stroke
  • Diseases with severe damage to other organs
  • Moderate to severe aortic insufficiency
  • Significant pulmonary hypertension
  • 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
  • Patients with cardiac pacemakers
  • History of moderate to severe cognitive impairment or psychiatric disorders
  • History of malignancy
  • Lower extremity arterial thrombosis
  • Various bleeding disorders, bleeding tendencies, or use of anticoagulants, Prothrombin international normalized ratio （INR） >2.0
  • Dissection aneurysm, aortic aneurysm, cerebral aneurysm
  • Pregnancy
  • Patients with arterial clamp after craniocerebral operation
  • moyamoya patients

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in China

  • First Affiliated Hospital of Xian Jiaotong UniversityXi'an, ChinaContact: Wanghuan Dun, doctorTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • real EECPTreatment being tested
  • sham EECPSham treatment, for comparison
  • Health ControlNo study treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Neuroimaging Prediction Study Based on Multi-model Magnetic Resonance Imaging Technology to Evaluate the Therapeutic Effect of EECP on HR-NICE Patients
Plain-language title
Tests a pressure-wave device in people with ischemic stroke riskGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05718622, who can take part
Record updated
24 February 2023