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

NCT05718622 | Recruiting

• 1 other identifier: XJTU1AF-CRF-2022-023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• the change of stroke impact scale (SIS)

  Stroke Impact Scale （SIS） is an evaluation of stroke severity affecting daily life and health. It includes 59 items in 8 domains among strength, hand function, mobility, activities of daily living, memory, communication, emotion and social participation. Each item is scored on a scale of 1 - 5 and each domain is scored on a scale of 0 - 100 after conversion. The sum score of 8 domains is set as the total of SIS. A higher score corresponds to a better outcome. In this trial, SIS is evaluated before and after the EECP treatment course, total score of each evaluation is calculated and the change of them is set as the primary outcome measure.

  baseline(the day before the first EECP treatment); after a course of EECP treatment(14 days)

Secondary Outcomes (1)

• the change of cerebral perfusion

  baseline(the day before the first EECP treatment); after a course of EECP treatment(14 days)

Study Arms (3)

real EECP

EXPERIMENTAL

Device: real EECP

sham EECP

SHAM COMPARATOR

Device: sham EECP

Health Control

NO INTERVENTION

Interventions

real EECP DEVICE

Real EECP treatment is delivered 45min per day for 14 sessions continuously. The treatment pressure sets at 150 millimeters of mercury.

real EECP

sham EECP DEVICE

Sham EECP treatment is delivered 45min per day for 14 sessions continuously. The treatment pressure sets at 75 millimeters of mercury.

sham EECP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Wanghuan Dun, doctor

CONTACT

0086-18092706568; wanghuandun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: November 10, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: February 24, 2023

Record last verified: 2022-11

Locations

CN (1)