Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05718622
Status:
RECRUITING
Last Update Posted:
2023-02-24
First Post:
2023-01-30
Brief Title:
Evaluation and Prediction of the Effect of EECP on HR-NICE Patients
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 its 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 Whats 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None