StrokeRICA-2NCT05982015
Efficacy Study II on Remote Ischemic Conditioning for the Prevention of Stroke-Associated Pneumonia
A study testing Remote ischemic conditioning in people with Stroke, run by Capital Medical University at 1 site in China.
Trial summary
Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,651 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2024to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset
Read the 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
- Conditions
- Stroke
- Being tested
- Remote ischemic conditioning, Sham remote ischemic conditioning
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
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 conditioningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Remote ischemic conditioning (RIC) -200mmHg and best medical management Receives: Device: Remote ischemic conditioning |
| Sham group | Sham comparator | Remote ischemic conditioning (RIC) -60mmHg and best medical management Receives: Device: Sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke-associated pneumonia
Stroke-associated pneumonia incidence rate
Measured: 7 days
Secondary outcomes (12)
Physician diagnosed pneumonia
Physician diagnosed pneumonia incidence rate
Measured: 7 days
Physician diagnosed pneumonia
Physician diagnosed pneumonia incidence rate
Measured: 8-90 days
Modified Rankin scale score from 0 to 1
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.
Measured: 90 days after the onset of symptoms
Modified Rankin scale score from 0 to 2
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.
Measured: 90 days
Modified Rankin scale scores
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.
Measured: 90 days
EQ-5D-5L scores
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
Measured: 90 days
NIHSS stroke scale scores
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.
Measured: 24 hours
NIHSS stroke scale scores
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.
Measured: 7 days
Urinary tract infections
Urinary tract infections incidence rate
Measured: 7 days
Infections
Infections incidence rate
Measured: 7 days
All-cause mortality
All-cause mortality incidence rate
Measured: 90 days
Inpatient days
Total inpatient days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start22 Jan 2024
- Primary completion19 Sep 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Chuanjie Wu, M.D., Study director, Xuanwu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982015
- Sponsor's protocol ID
- RICA-2
- Acronym
- RICA-2
- Status last verified
- Dec 2024
- First submitted
- 1 Aug 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Westendorp WF, Vermeij JD, Zock E, Hooijenga IJ, Kruyt ND, Bosboom HJ, Kwa VI, Weisfelt M, Remmers MJ, ten Houten R, Schreuder AH, Vermeer SE, van Dijk EJ, Dippel DW, Dijkgraaf MG, Spanjaard L, Vermeulen M, van der Poll T, Prins JM, Vermeij FH, Roos YB, Kleyweg RP, Kerkhoff H, Brouwer MC, Zwinderman AH, van de Beek D, Nederkoorn PJ; PASS investigators. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet. 2015 Apr 18;385(9977):1519-26. doi: 10.1016/S0140-6736(14)62456-9. Epub 2015 Jan 20.
PubMed 25612858Kalra L, Irshad S, Hodsoll J, Simpson M, Gulliford M, Smithard D, Patel A, Rebollo-Mesa I; STROKE-INF Investigators. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet. 2015 Nov 7;386(10006):1835-44. doi: 10.1016/S0140-6736(15)00126-9. Epub 2015 Sep 3.
PubMed 26343840Hoffmann S, Harms H, Ulm L, Nabavi DG, Mackert BM, Schmehl I, Jungehulsing GJ, Montaner J, Bustamante A, Hermans M, Hamilton F, Gohler J, Malzahn U, Malsch C, Heuschmann PU, Meisel C, Meisel A; PREDICT Investigators. Stroke-induced immunodepression and dysphagia independently predict stroke-associated pneumonia - The PREDICT study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3671-3682. doi: 10.1177/0271678X16671964. Epub 2016 Oct 14.
PubMed 27733675Chamorro A, Meisel A, Planas AM, Urra X, van de Beek D, Veltkamp R. The immunology of acute stroke. Nat Rev Neurol. 2012 Jun 5;8(7):401-10. doi: 10.1038/nrneurol.2012.98.
PubMed 22664787Iadecola C, Anrather J. The immunology of stroke: from mechanisms to translation. Nat Med. 2011 Jul 7;17(7):796-808. doi: 10.1038/nm.2399.
PubMed 21738161Chamorro A, Urra X, Planas AM. Infection after acute ischemic stroke: a manifestation of brain-induced immunodepression. Stroke. 2007 Mar;38(3):1097-103. doi: 10.1161/01.STR.0000258346.68966.9d. Epub 2007 Jan 25.
PubMed 17255542Randhawa PK, Bali A, Jaggi AS. RIPC for multiorgan salvage in clinical settings: evolution of concept, evidences and mechanisms. Eur J Pharmacol. 2015 Jan 5;746:317-32. doi: 10.1016/j.ejphar.2014.08.016. Epub 2014 Aug 28.
PubMed 25176179Jia L, Hou C, Mei Q, Zhang B, Zhao W, Zhao H, Shang S, Guo X, Ma Q, Song H, Li C, Meng R, Xu W, Wang Y, Xu G, Wu C, Ji X, Investigators FTR. Remote ischemic conditioning for the prevention of stroke-associated pneumonia (RICA-2): protocol for a multicenter, prospective, randomized, double-blind, sham-controlled phase III trial. Trials. 2025 Oct 16;26(1):419. doi: 10.1186/s13063-025-09140-x.
PubMed 41102804
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05982015
- Acronym / sponsor ID
- RICA-2 / RICA-2
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,651 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Remote ischemic conditioningRemote ischemic conditioning (RIC) -200mmHg and best medical management |
| Sham group | Sham comparator | Device: Sham remote ischemic conditioningRemote ischemic conditioning (RIC) -60mmHg and best medical management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningThe 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. | Device | Intervention group |
| Sham remote ischemic conditioningThe 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. | Device | Sham group |
Primary outcome
Stroke-associated pneumonia
Time frame: 7 days
Stroke-associated pneumonia incidence rate
12 secondary outcomes
Physician diagnosed pneumonia
Time frame: 7 days
Physician diagnosed pneumonia
Time frame: 8-90 days
Modified Rankin scale score from 0 to 1
Time frame: 90 days after the onset of symptoms
Modified Rankin scale score from 0 to 2
Time frame: 90 days
Modified Rankin scale scores
Time frame: 90 days
EQ-5D-5L scores
Time frame: 90 days
NIHSS stroke scale scores
Time frame: 24 hours
NIHSS stroke scale scores
Time frame: 7 days
Urinary tract infections
Time frame: 7 days
Infections
Time frame: 7 days
All-cause mortality
Time frame: 90 days
Inpatient days
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 25612858Westendorp WF, Vermeij JD, Zock E, Hooijenga IJ, Kruyt ND, Bosboom HJ, Kwa VI, Weisfelt M, Remmers MJ, ten Houten R, Schreuder AH, Vermeer SE, van Dijk EJ, Dippel DW, Dijkgraaf MG, Spanjaard L, Vermeulen M, van der Poll T, Prins JM, Vermeij FH, Roos YB, Kleyweg RP, Kerkhoff H, Brouwer MC, Zwinderman AH, van de Beek D, Nederkoorn PJ; PASS investigators. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet. 2015 Apr 18;385(9977):1519-26. doi: 10.1016/S0140-6736(14)62456-9. Epub 2015 Jan 20.
- Background: PubMed 26343840Kalra L, Irshad S, Hodsoll J, Simpson M, Gulliford M, Smithard D, Patel A, Rebollo-Mesa I; STROKE-INF Investigators. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet. 2015 Nov 7;386(10006):1835-44. doi: 10.1016/S0140-6736(15)00126-9. Epub 2015 Sep 3.
- Background: PubMed 27733675Hoffmann S, Harms H, Ulm L, Nabavi DG, Mackert BM, Schmehl I, Jungehulsing GJ, Montaner J, Bustamante A, Hermans M, Hamilton F, Gohler J, Malzahn U, Malsch C, Heuschmann PU, Meisel C, Meisel A; PREDICT Investigators. Stroke-induced immunodepression and dysphagia independently predict stroke-associated pneumonia - The PREDICT study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3671-3682. doi: 10.1177/0271678X16671964. Epub 2016 Oct 14.
- Background: PubMed 22664787Chamorro A, Meisel A, Planas AM, Urra X, van de Beek D, Veltkamp R. The immunology of acute stroke. Nat Rev Neurol. 2012 Jun 5;8(7):401-10. doi: 10.1038/nrneurol.2012.98.
- Background: PubMed 21738161Iadecola C, Anrather J. The immunology of stroke: from mechanisms to translation. Nat Med. 2011 Jul 7;17(7):796-808. doi: 10.1038/nm.2399.
- Background: PubMed 17255542Chamorro A, Urra X, Planas AM. Infection after acute ischemic stroke: a manifestation of brain-induced immunodepression. Stroke. 2007 Mar;38(3):1097-103. doi: 10.1161/01.STR.0000258346.68966.9d. Epub 2007 Jan 25.
- Background: PubMed 25176179Randhawa PK, Bali A, Jaggi AS. RIPC for multiorgan salvage in clinical settings: evolution of concept, evidences and mechanisms. Eur J Pharmacol. 2015 Jan 5;746:317-32. doi: 10.1016/j.ejphar.2014.08.016. Epub 2014 Aug 28.
- Derived from this study: PubMed 41102804Jia L, Hou C, Mei Q, Zhang B, Zhao W, Zhao H, Shang S, Guo X, Ma Q, Song H, Li C, Meng R, Xu W, Wang Y, Xu G, Wu C, Ji X, Investigators FTR. Remote ischemic conditioning for the prevention of stroke-associated pneumonia (RICA-2): protocol for a multicenter, prospective, randomized, double-blind, sham-controlled phase III trial. Trials. 2025 Oct 16;26(1):419. doi: 10.1186/s13063-025-09140-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuanjie Wu, M.D. study director
Xuanwu Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Stroke, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke-associated pneumonia (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982015, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.