Clinical trial NCT05982015: Efficacy Study II on Remote Ischemic Conditioning for the Prevention of Stroke-Associated Pneumonia
Official title: Multicenter, Randomized, Double-blind, Pseudo Treatment-controlled Clinical Study on the Efficacy and Safety of Remote Ischemic Conditioning in Preventing Stroke-associated Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 1651
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Stroke-associated pneumonia
timeFrame: 7 days
Secondary outcomes:
measure: Physician diagnosed pneumonia
timeFrame: 7 days
measure: Physician diagnosed pneumonia
timeFrame: 8-90 days
measure: Modified Rankin scale score from 0 to 1
timeFrame: 90 days after the onset of symptoms
measure: Modified Rankin scale score from 0 to 2
timeFrame: 90 days
measure: Modified Rankin scale scores
timeFrame: 90 days
measure: EQ-5D-5L scores
timeFrame: 90 days
measure: NIHSS stroke scale scores
timeFrame: 24 hours
measure: NIHSS stroke scale scores
timeFrame: 7 days
measure: Urinary tract infections
timeFrame: 7 days
measure: Infections
timeFrame: 7 days
measure: All-cause mortality
timeFrame: 90 days
measure: Inpatient days
timeFrame: 90 days
Other outcomes:
measure: Spots of skin bleeding within 7 days
timeFrame: 7 days
measure: Red or swollen arms within 7 days
timeFrame: 7 days
measure: Dizziness within 7 days
timeFrame: 7 days
measure: Nausea within 7 days
timeFrame: 7 days
measure: Palpitations within 7 days.
timeFrame: 7 days
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital of Capital Medical University
name: Chuanjie Wu, M.D.
role: STUDY_DIRECTOR
References:
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