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

Primary Purpose

Stroke, Ischemic

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
real EECP
sham EECP
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • First Affiliated Hospital of Xian Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

real EECP

sham EECP

Health Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

the change of cerebral perfusion
Arterial spin labeling(ASL) is used for the evaluation of cerebral perfusion before and after the EECP treatment. Cerebral blood flow(CBF) map is calculated after each scan. The difference of these two CBF maps is set as the secondary outcome measures.

Full Information

First Posted
January 30, 2023
Last Updated
February 22, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05718622
Brief Title
Evaluation and Prediction of the Effect of EECP on HR-NICE Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Due to the conventional impression that mild stroke would lead to a good recovery outcome rather than disability, it is easy for patients or clinicians to ignore or delay the secondary prevention therapy. However, the latest research findings indicate that these patients have a high risk of neurological deterioration within hours to days after the onset of the disease. The risk of recurrence within 90 days is much higher than normal people as well. These patients are at greater risk complicating with atherosclerotic stenosis of the large arteries. This study designs a randomized, double-blind, controlled clinical trial to observe the improvement effect of EECP in HR-NICE patients. Random numbers are used to divide HR-NICE patients into two groups with true or sham EECP treatment separately. All the patients and technicians are blind of the group assignments of the subjects except the therapist responsible for setting the parameters of each patient's treatment. By observing the difference of Stroke Impact Scale before and after a course of EECP treatment, the investigators explore its effect on symptom improvement in HR-NICE patients. Based on multi-model magnetic resonance imaging, hematological parameter detection and genetic test, it's comprehensive to clarify the central neural features and peripheral abnormalities of HR-NICE patients, so as to provide objective proof for efficacy evaluation of pre-existing neural damage. What's more, on the basis that neuroimaging characteristics and inflammatory factors have important effects on the progression of disease as well as the presentation of symptoms, this study intends to reveal the potential mechanism of EECP to improve performance of central neural system on different neuroimaging aspects and find sensitive neuroimaging biomarkers in predicting the therapeutic effect of EECP. This study is not only contributing to explore the validity of EECP on HR-NICE patients, but also exploring the intrinsic and peripheral mechanism for classifying sensitive population based on neuroimaging and other predictive markers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
real EECP
Arm Type
Experimental
Arm Title
sham EECP
Arm Type
Sham Comparator
Arm Title
Health Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
real EECP
Intervention Description
Real EECP treatment is delivered 45min per day for 14 sessions continuously. The treatment pressure sets at 150 millimeters of mercury.
Intervention Type
Device
Intervention Name(s)
sham EECP
Intervention Description
Sham EECP treatment is delivered 45min per day for 14 sessions continuously. The treatment pressure sets at 75 millimeters of mercury.
Primary Outcome Measure Information:
Title
the change of stroke impact scale (SIS)
Description
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.
Time Frame
baseline(the day before the first EECP treatment); after a course of EECP treatment(14 days)
Secondary Outcome Measure Information:
Title
the change of cerebral perfusion
Description
Arterial spin labeling(ASL) is used for the evaluation of cerebral perfusion before and after the EECP treatment. Cerebral blood flow(CBF) map is calculated after each scan. The difference of these two CBF maps is set as the secondary outcome measures.
Time Frame
baseline(the day before the first EECP treatment); after a course of EECP treatment(14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanghuan Dun, doctor
Phone
0086-18092706568
Email
wanghuandun@163.com
Facility Information:
Facility Name
First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanghuan Dun, doctor
Phone
0086-18092706568
Email
wanghuandun@163.com

12. IPD Sharing Statement

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

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