Effect of External Counter Pulsation on Ischemic Stroke

NCT ID: NCT03075137

Last Updated: 2017-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-10
• Study Completion Date: 2019-06-30

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.

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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke; external counter pulsation; mRS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

External counter pulsation (ECP)

Intervention Type: DEVICE

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

Guideline-driven standard medical treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Research Institute, The Chinese University Hong Kong

UNKNOWN

Sponsor Role: collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Eighth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Guifu Wu

Eighth Affiliated Hospital, Sun Yat-Sen University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guifu Wu, PhD

Role: STUDY_CHAIR

Eighth Affiliated Hospital, Sun Yat-sen University

Locations

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

Countries

China

Central Contacts

Guifu Wu, PhD

Role: CONTACT

Phone: +8615989892111

Email: wuguifu@mail.sysu.edu.cn

Jianhang Du, PhD

Role: CONTACT

Phone: +8613652851566

Email: zsudjhang@163.com

Facility Contacts

Li Xiong, PhD

Role: primary

Bing Xia, PhD

Role: primary

Haifeng Yuan, PhD

Role: primary

Other Identifiers

SYSU8002

Identifier Type: -

Identifier Source: org_study_id