Efficacy Study II on Remote Ischemic Conditioning for the Prevention of Stroke-Associated Pneumonia (RICA-2)

December 20, 2024 updated by: Ji Xunming,MD,PhD, Capital Medical University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1651

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Xuanwu Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Remote ischemic conditioning (RIC) -200mmHg and best medical management
Device: 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 200 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.
Sham Comparator: Sham group
Remote ischemic conditioning (RIC) -60mmHg and best medical management
Device: Sham 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stroke-associated pneumonia
Time Frame: 7 days
Stroke-associated pneumonia incidence rate
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physician diagnosed pneumonia
Time Frame: 7 days
Physician diagnosed pneumonia incidence rate
7 days
Physician diagnosed pneumonia
Time Frame: 8-90 days
Physician diagnosed pneumonia incidence rate
8-90 days
Urinary tract infections
Time Frame: 7 days
Urinary tract infections incidence rate
7 days
Infections
Time Frame: 7 days
Infections incidence rate
7 days
All-cause mortality
Time Frame: 90 days
All-cause mortality incidence rate
90 days
Inpatient days
Time Frame: 90 days
Total inpatient days
90 days
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.

  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.
90 days after the onset of symptoms
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.

  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.
90 days
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.

  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.
90 days
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
90 days
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.
24 hours
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.
7 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spots of skin bleeding within 7 days
Time Frame: 7 days
Number of subjects who have skin bleeding points within 7 days
7 days
Red or swollen arms within 7 days
Time Frame: 7 days
Number of subjects who have red or swollen arms within 7 days
7 days
Dizziness within 7 days
Time Frame: 7 days
Number of subjects who have dizziness within 7 days
7 days
Nausea within 7 days
Time Frame: 7 days
Number of subjects who have nausea within 7 days
7 days
Palpitations within 7 days.
Time Frame: 7 days
Number of subjects who have palpitations within 7 days.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chuanjie Wu, M.D., Xuanwu Hospital of Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RICA-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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