NCT05718622Recruiting
Evaluation and Prediction of the Effect of EECP on HR-NICE Patients
A Neuroimaging Prediction Study Based on Multi-model Magnetic Resonance Imaging Technology to Evaluate the Therapeutic Effect of EECP on HR-NICE Patients
Source: ClinicalTrials.gov · Last updated 24 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 30 Jan 2023
- Start date
- 10 Nov 2022
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Diseases
- Stroke
- NCT number
- NCT05718622
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 10 Nov 2022 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with metal implants, such as metal joints, shrapnel and orbital foreign bodies
Other illness
- 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
Lab values
- Various bleeding disorders, bleeding tendencies, or use of anticoagulants, Prothrombin international normalized ratio （INR） \>2.0
Other
- Dissection aneurysm, aortic aneurysm, cerebral aneurysm
- Pregnancy
- Patients with arterial clamp after craniocerebral operation
- moyamoya patients
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.