Stroke, IschemicNCT05718622
Evaluation and Prediction of the Effect of EECP on HR-NICE Patients
A study testing real EECP in people with Stroke, Ischemic, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- real EECP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2022to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Wanghuan Dun, doctor, 0086-18092706568, wanghuandun@163.com
About this study
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
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.
Read the 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.
- Conditions
- Stroke, Ischemic
- Being tested
- real EECP, sham EECP
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real EECPDevice
Real EECP treatment is delivered 45min per day for 14 sessions continuously. The treatment pressure sets at 150 millimeters of mercury.
sham EECPDevice
Sham EECP treatment is delivered 45min per day for 14 sessions continuously. The treatment pressure sets at 75 millimeters of mercury.
| Study group | Role | What they receive |
|---|---|---|
| real EECP | Experimental | Not described Receives: Device: real EECP |
| sham EECP | Sham comparator | Not described Receives: Device: sham EECP |
| Health Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline(the day before the first EECP treatment); after a course of EECP treatment(14 days)
Secondary outcomes (1)
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.
Measured: baseline(the day before the first EECP treatment); after a course of EECP treatment(14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start10 Nov 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718622
- Sponsor's protocol ID
- XJTU1AF-CRF-2022-023
- Status last verified
- Nov 2022
- First submitted
- 30 Jan 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05718622
- Acronym / sponsor ID
- XJTU1AF-CRF-2022-023
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| real EECP | Experimental | Device: real EECP |
| sham EECP | Sham comparator | Device: sham EECP |
| Health Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- Progressive stroke
- Diseases with severe damage to other organs
- Moderate to severe aortic insufficiency
- Dissection aneurysm, aortic aneurysm, cerebral aneurysm
- Significant pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real EECPReal EECP treatment is delivered 45min per day for 14 sessions continuously. The treatment pressure sets at 150 millimeters of mercury. | Device | real EECP |
| sham EECPSham EECP treatment is delivered 45min per day for 14 sessions continuously. The treatment pressure sets at 75 millimeters of mercury. | Device | sham EECP |
Primary outcome
the change of stroke impact scale (SIS)
Time frame: baseline(the day before the first EECP treatment); after a course of EECP treatment(14 days)
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.
1 secondary outcome
the change of cerebral perfusion
Time frame: baseline(the day before the first EECP treatment); after a course of EECP treatment(14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real EECP in people with Stroke, Ischemic, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanghuan Dun, doctor (0086-18092706568, wanghuandun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of stroke impact scale (SIS) (time frame: baseline(the day before the first EECP treatment); after a course of EECP treatment(14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.