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Completed

NCT Number: NCT05982015

Efficacy Study II on Remote Ischemic Conditioning for the Prevention of Stroke-Associated Pneumonia

Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, China

About this study

Verifying whether remote ischemic adaptation can reduce the occurrence and safety of stroke related pneumonia in acute stroke patients within 24 hours of onset

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

remote ischemic conditioning

Device

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.

Sham remote ischemic conditioning

Device

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.

Primary outcomes

  1. Stroke-associated pneumonia

    Time frame: 7 days

    Stroke-associated pneumonia incidence rate

Secondary outcomes

  1. Physician diagnosed pneumonia

    Time frame: 7 days

    Physician diagnosed pneumonia incidence rate

  2. Physician diagnosed pneumonia

    Time frame: 8-90 days

    Physician diagnosed pneumonia incidence rate

  3. Modified Rankin scale score from 0 to 1

    Time frame: 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.

    • point: Symptoms present but no significant disability; able to carry out all usual duties and activities.
    • 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.

  4. Modified Rankin scale score from 0 to 2

    Time frame: 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.

    • point: Symptoms present but no significant disability; able to carry out all usual duties and activities.
    • 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.

  5. Modified Rankin scale scores

    Time frame: 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.

    • point: Symptoms present but no significant disability; able to carry out all usual duties and activities.
    • 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.

  6. EQ-5D-5L scores

    Time frame: 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

  7. NIHSS stroke scale scores

    Time frame: 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.

  8. NIHSS stroke scale scores

    Time frame: 7 days

    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.

  9. Urinary tract infections

    Time frame: 7 days

    Urinary tract infections incidence rate

  10. Infections

    Time frame: 7 days

    Infections incidence rate

  11. All-cause mortality

    Time frame: 90 days

    All-cause mortality incidence rate

  12. Inpatient days

    Time frame: 90 days

    Total inpatient days

Other outcomes

  1. Spots of skin bleeding within 7 days

    Time frame: 7 days

    Number of subjects who have skin bleeding points within 7 days

  2. Red or swollen arms within 7 days

    Time frame: 7 days

    Number of subjects who have red or swollen arms within 7 days

  3. Dizziness within 7 days

    Time frame: 7 days

    Number of subjects who have dizziness within 7 days

  4. Nausea within 7 days

    Time frame: 7 days

    Number of subjects who have nausea within 7 days

  5. Palpitations within 7 days.

    Time frame: 7 days

    Number of subjects who have palpitations within 7 days.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Multicenter, Randomized, Double-blind, Pseudo Treatment-controlled Clinical Study on the Efficacy and Safety of Remote Ischemic Conditioning in Preventing Stroke-associated Pneumonia

Acronym: RICA-2

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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