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Effect of External Counter Pulsation on Ischemic Stroke

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Врската е зачувана во таблата со исечоци
Статус
Спонзори
Eighth Affiliated Hospital, Sun Yat-sen University
Соработници
Shenzhen Research Institute, The Chinese University Hong Kong
Second Affiliated Hospital of Xi'an Jiaotong University
The Second Affiliated Hospital of Zhengzhou University

Клучни зборови

Апстракт

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.

Опис

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.

Датуми

Последен пат проверено: 11/30/2017
Прво доставено: 02/27/2017
Поднесено е проценето запишување: 03/07/2017
Прво објавено: 03/08/2017
Последното ажурирање е доставено: 12/11/2017
Последно ажурирање објавено: 12/12/2017
Крај на датумот на започнување на студијата: 06/09/2018
Проценет датум на примарно завршување: 05/30/2019
Проценет датум на завршување на студијата: 06/29/2019

Состојба или болест

Ischemic Stroke

Интервенција / третман

Device: External Counter Pulsation (ECP) group

Фаза

Фаза 3

Групи за раце

РакаИнтервенција / третман
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) group
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

Критериуми за подобност

Возраст подобни за студии 18 Years До 18 Years
Полови квалификувани за студииAll
Прифаќа здрави волонтериДа
Критериуми

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

Исход

Мерки на примарниот исход

1. modified Rankin Scale (mRS) score [Change from Baseline at 3 months]

3-month mRS score after stroke

Секундарни мерки на исходот

1. NIH Stroke Scale (NIHSS) score [Change from Baseline at 3 months]

3-month NIHSS score after stroke

2. Barthel Index (BI) [Change from Baseline at 3 months]

3-month BI after stroke

3. mini-mental state examination (MMSE) Score [Change from Baseline at 3 months]

3-month MMSE after stroke

4. Ischemic area of Cerebral CT image [Change from Baseline at 3 months]

Ischemic area of 3-month Cerebral CT image

5. Transcranial doppler (TCD) flow velocities [Change from Baseline at 3 months]

transcranial doppler (TCD) flow velocities

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