Effect of External Counter Pulsation on Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03075137
• Other study ID #: SYSU8002
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 28, 2017
• Last updated: December 12, 2017
• Start date: June 10, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2017
• Source: Eighth Affiliated Hospital, Sun Yat-sen University
• Contact: Guifu Wu, PhD
• Phone: +8615989892111
• Email: wuguifu[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 380
• Est. completion date: June 30, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Shenzhen Research Institute, The Chinese University Hong Kong	Shenzhen	Guangdong
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (4)

Lead Sponsor	Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University	Second Affiliated Hospital of Xi'an Jiaotong University, Shenzhen Research Institute, The Chinese University Hong Kong, The Second Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale (mRS) score	3-month mRS score after stroke	Change from Baseline at 3 months
Secondary	NIH Stroke Scale (NIHSS) score	3-month NIHSS score after stroke	Change from Baseline at 3 months
Secondary	Barthel Index (BI)	3-month BI after stroke	Change from Baseline at 3 months
Secondary	mini-mental state examination (MMSE) Score	3-month MMSE after stroke	Change from Baseline at 3 months
Secondary	Ischemic area of Cerebral CT image	Ischemic area of 3-month Cerebral CT image	Change from Baseline at 3 months
Secondary	Transcranial doppler (TCD) flow velocities	transcranial doppler (TCD) flow velocities	Change from Baseline at 3 months