Effect of External Counter Pulsation on Ischemic Stroke

Effect of External Counter Pulsation on IschemicStroke (ECP-STROKE)

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: External counter pulsation (ECP)

Detailed Description

Cardiovascular disease is the leading cause of mortality worldwide, accounting for 17.5 million deaths per year; 6.7 million of these deaths are related to stroke. Over 80% of strokes are classified as ischemic. External counter pulsation (ECP) is a non-invasive method which 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. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved carotid perfusion pressure. Cumulative evidences demonstrate that ECP can augment peak diastolic and mean middle cerebral artery flow velocities, accelerate rehabilitation after stroke, however, no multi-center study on the effect of ECP on the prognosis of stroke has been reported. Thus, this study is designed to enroll 380 subjects with ischemic stroke after evaluation of glycolipid metabolism, heart function, transcranial doppler (TCD) flow velocities, endothelial function, NIHSS, BI and MMSE score, they will be randomized into ECP intervention or control group. All subjects receive Guideline-driven standard medical treatment, ECP will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks. Up to the end of ECP intervention, mRS of subjects will be follow up to 3 months, meanwhile, items as above will be retested for comparison.

• Study Type: Interventional
• Enrollment (Anticipated): 380
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Guifu Wu, PhD; Phone Number: +8615989892111; Email: wuguifu@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China
      • Shenzhen Research Institute, The Chinese University Hong Kong
      • Contact: Li Xiong, PhD; Phone Number: +8613688847419
  • Henan
    • Zhengzhou, Henan, China
      • The Second Affiliated Hospital of Zhengzhou University
      • Contact: Bing Xia, PhD; Phone Number: +86 13663839489
  • Shanxi
    • Xi'an, Shanxi, China
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Haifeng Yuan, PhD; Phone Number: +86 13572234796

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of ischemic stroke
• Exclusion cerebral hemorrhage after CT scan
• NIH Stroke Scale (NIHSS)≥4
• Modified Rankin Scale (mRS) 0-1
• Signed informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: External Counter Pulsation (ECP) group; A 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.	Device: External counter pulsation (ECP); 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.
No Intervention: Control group; Guideline-driven standard medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin Scale （mRS） score	3-month mRS score after stroke	Change from Baseline at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH Stroke Scale (NIHSS) score	3-month NIHSS score after stroke	Change from Baseline at 3 months
Barthel Index (BI)	3-month BI after stroke	Change from Baseline at 3 months
mini-mental state examination (MMSE) Score	3-month MMSE after stroke	Change from Baseline at 3 months
Ischemic area of Cerebral CT image	Ischemic area of 3-month Cerebral CT image	Change from Baseline at 3 months
Transcranial doppler (TCD) flow velocities	transcranial doppler (TCD) flow velocities	Change from Baseline at 3 months

Collaborators and Investigators

• Sponsor: Eighth Affiliated Hospital, Sun Yat-sen University
• Collaborators: Second Affiliated Hospital of Zhengzhou University; Second Affiliated Hospital of Xi'an Jiaotong University; Shenzhen Research Institute, The Chinese University Hong Kong
• Investigators: Study Chair: Guifu Wu, PhD, Eighth Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 10, 2018
• Primary Completion (Anticipated): May 31, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: ischemic stroke; mRS; external counter pulsation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: SYSU8002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No