Effect of External Counter Pulsation on Ischemic Stroke
Клучни зборови
Апстракт
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
Интервенција / третман
Device: External Counter Pulsation (ECP) group
Фаза
Групи за раце
Рака | Интервенција / 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 студии | All |
Прифаќа здрави волонтери | Да |
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]
Секундарни мерки на исходот
1. NIH Stroke Scale (NIHSS) score [Change from Baseline at 3 months]
2. Barthel Index (BI) [Change from Baseline at 3 months]
3. mini-mental state examination (MMSE) Score [Change from Baseline at 3 months]
4. Ischemic area of Cerebral CT image [Change from Baseline at 3 months]
5. Transcranial doppler (TCD) flow velocities [Change from Baseline at 3 months]