Effect of External Counter Pulsation on Ischemic Stroke
1 other identifier
interventional
380
1 country
3
Brief Summary
Stroke is a prevalent atherosclerosis vascular disease with high mortality, external counter pulsation (ECP) is an approved noninvasive therapy for angina, congestive heart failure, myocardial infarction, and cardiogenic shock that augments blood flow to cardiac and systemic circuits, which improves the flow volume in the carotid. Though ECP is Ⅱa recommendation for stroke management, no multi-center control clinical study has been reported for prognosis of stroke. The aim of this study is to evaluate the effect of ECP on stoke. To address this assumption, investigators enroll subjects with ischemic stroke and randomized into control or ECP group, the ECP intervention will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks. The primary endpoint is mRS score in 3 months, secondary endpoints include NIHSS, BI and MMSE score, recurrence of stroke in 3 months, glycolipid metabolism, transcranial doppler (TCD) flow velocities and endothelial function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2018
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedStudy Start
First participant enrolled
June 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedDecember 13, 2017
December 1, 2017
12 months
February 28, 2017
December 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modified Rankin Scale （mRS） score
3-month mRS score after stroke
Change from Baseline at 3 months
Secondary Outcomes (5)
NIH Stroke Scale (NIHSS) score
Change from Baseline at 3 months
Barthel Index (BI)
Change from Baseline at 3 months
mini-mental state examination (MMSE) Score
Change from Baseline at 3 months
Ischemic area of Cerebral CT image
Change from Baseline at 3 months
Transcranial doppler (TCD) flow velocities
Change from Baseline at 3 months
Study Arms (2)
External Counter Pulsation (ECP) group
EXPERIMENTALA standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.
Control group
NO INTERVENTIONGuideline-driven standard medical treatment
Interventions
standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of ischemic stroke
- NIH Stroke Scale (NIHSS)≥4
- Modified Rankin Scale (mRS) 0-1
- Signed informed consent
You may not qualify if:
- Obvious aortic insufficiency;
- Aortic aneurysm or aortic dissection;
- Coronary fistula or severe coronary aneurysm;
- Not controlled bleeding disease with INR\>2.0 ;
- Symptomatic Congestive heart failure
- Valvular heart disease, congenital heart diseases, cardiomyopathies
- Cerebral hemorrhage within six months;
- Uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg;
- Lower limb infection;
- Deep venous thrombosis;
- Progressive malignancies or diseases with poor prognosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Shenzhen Research Institute, The Chinese University Hong Kong
Shenzhen, Guangdong, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guifu Wu, PhD
Eighth Affiliated Hospital, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Eighth Affiliated Hospital, Sun Yat-Sen University
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 9, 2017
Study Start
June 10, 2018
Primary Completion
May 31, 2019
Study Completion
June 30, 2019
Last Updated
December 13, 2017
Record last verified: 2017-12