Stroke
Conditions
Brief summary
Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset
Detailed description
Verifying whether remote ischemic adaptation can reduce the occurrence and safety of stroke related pneumonia in acute stroke patients within 24 hours of onset
Interventions
DEVICERemote ischemic conditioning
The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.
DEVICESham remote ischemic conditioning
The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 60 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≥18 years old; * Diagnosis of acute ischemic stroke; * Remote ischemic conditioning or sham-remote ischemic conditioning can be treated within 24 hours after stroke onset * NIHSS score≥4; * Subject or his or her legally authorized representative was able to provide informed consent.
Exclusion criteria
* During the screening period, body temperature ≥ 38 ℃; * Evidence of lung infection, urinary tract infection or other infectious diseases during the screening period * Expected lifespan less than 7 days * Mechanical ventilation is expected to be required within 7 days; * Anti-infective drug were used within 7 days prior to stroke; * Uncontrolled hypertension with medication (defined as systolic blood pressure ≥200 mmHg and/or diastolic blood pressure ≥110 mmHg); * There are contraindications for remote ischemic conditioning (such as skin and soft tissue injury, fractures, peripheral arterial disease, etc. in the upper limbs); * History of autoimmune disease or malignancies; * Use of immunosuppressive drug within the preceding 3 months; * Pregnant or lactating, or pregnancy test positive; * Current participation in another investigational trial; * Other conditions are not suitable for this trial as evaluated by researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke-associated pneumonia | 7 days | Stroke-associated pneumonia incidence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin scale scores | 90 days | Shift analysis. In medical and clinical research, the modified Rankin Scale (mRS) is used to assess the degree of disability in patients after a stroke. The scale ranges from 0 to 6, where 0 indicates no symptoms and 6 indicates death. On the mRS scale, scores from 0 to 2 usually indicate no or slight disability. Specifically: 0 points: No symptoms. 1. point: Symptoms present but no significant disability; able to carry out all usual duties and activities. 2. points: Slight disability; able to look after own affairs without assistance but unable to carry out all previous activities. Therefore, in clinical research, if a treatment or intervention increases the proportion of patients scoring 0 to 2 on the mRS scale, it is generally considered a positive outcome. This means that more patients have a better functional status and lower degree of disability after treatment. |
| NIHSS stroke scale scores | 24 hours | The scores of NIHSS stroke scale. The total NIHSS score can range from 0 to 42, with: 0: Indicating no stroke symptoms. 1-4: Indicating a minor stroke. 5-15: Indicating a moderate stroke. 16-20: Indicating a moderate to severe stroke. 21-42: Indicating a severe stroke. The NIHSS is useful in evaluating the effect of acute stroke treatments, predicting patient outcomes, and assessing the progression of stroke symptoms. |
| Urinary tract infections | 7 days | Urinary tract infections incidence rate |
| Infections | 7 days | Infections incidence rate |
| All-cause mortality | 90 days | All-cause mortality incidence rate |
| Inpatient days | 90 days | Total inpatient days |
| Physician diagnosed pneumonia | 7 days | Physician diagnosed pneumonia incidence rate |
| Modified Rankin scale score from 0 to 1 | 90 days after the onset of symptoms | In medical and clinical research, the modified Rankin Scale (mRS) is used to assess the degree of disability in patients after a stroke. The scale ranges from 0 to 6, where 0 indicates no symptoms and 6 indicates death. On the mRS scale, scores from 0 to 2 usually indicate no or slight disability. Specifically: 0 points: No symptoms. 1. point: Symptoms present but no significant disability; able to carry out all usual duties and activities. 2. points: Slight disability; able to look after own affairs without assistance but unable to carry out all previous activities. Therefore, in clinical research, if a treatment or intervention increases the proportion of patients scoring 0 to 1 on the mRS scale, it is generally considered a positive outcome. This means that more patients have a better functional status and lower degree of disability after treatment. |
| Modified Rankin scale score from 0 to 2 | 90 days | In medical and clinical research, the modified Rankin Scale (mRS) is used to assess the degree of disability in patients after a stroke. The scale ranges from 0 to 6, where 0 indicates no symptoms and 6 indicates death. On the mRS scale, scores from 0 to 2 usually indicate no or slight disability. Specifically: 0 points: No symptoms. 1. point: Symptoms present but no significant disability; able to carry out all usual duties and activities. 2. points: Slight disability; able to look after own affairs without assistance but unable to carry out all previous activities. Therefore, in clinical research, if a treatment or intervention increases the proportion of patients scoring 0 to 2 on the mRS scale, it is generally considered a positive outcome. This means that more patients have a better functional status and lower degree of disability after treatment. |
| EQ-5D-5L scores | 90 days | The scores of EQ-5D-5L. The five dimensions included in EQ-5D-5L are: Mobility: This dimension assesses the person's ability to walk about. Self-Care: This evaluates the individual's ability to wash or dress themselves. Usual Activities: This covers work, study, housework, family or leisure activities. Pain/Discomfort: This measures the level of pain or discomfort experienced by the individual. Anxiety/Depression: This assesses the person's psychological state, in terms of levels of anxiety or depression. Each of these five dimensions has five levels of severity: Level 1: No problems Level 2: Slight problems Level 3: Moderate problems Level 4: Severe problems Level 5: Extreme problems |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dizziness within 7 days | 7 days | Number of subjects who have dizziness within 7 days |
| Nausea within 7 days | 7 days | Number of subjects who have nausea within 7 days |
| Palpitations within 7 days. | 7 days | Number of subjects who have palpitations within 7 days. |
| Red or swollen arms within 7 days | 7 days | Number of subjects who have red or swollen arms within 7 days |
| Spots of skin bleeding within 7 days | 7 days | Number of subjects who have skin bleeding points within 7 days |
Countries
China
Outcome results
None listed