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Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset
Verifying whether remote ischemic adaptation can reduce the occurrence and safety of stroke related pneumonia in acute stroke patients within 24 hours of onset
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Remote ischemic conditioning (RIC) -200mmHg and best medical management |
|
| Sham group | Sham Comparator | Remote ischemic conditioning (RIC) -60mmHg and best medical management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke-associated pneumonia | Stroke-associated pneumonia incidence rate | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Physician diagnosed pneumonia | Physician diagnosed pneumonia incidence rate | 7 days |
| Physician diagnosed pneumonia | Physician diagnosed pneumonia incidence rate |
| Measure | Description | Time Frame |
|---|---|---|
| Spots of skin bleeding within 7 days | Number of subjects who have skin bleeding points within 7 days | 7 days |
| Red or swollen arms within 7 days | Number of subjects who have red or swollen arms within 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chuanjie Wu, M.D. | Xuanwu Hospital of Capital Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25612858 | Background | 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. | |
| 26343840 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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. |
|
| 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.
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 | 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.
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 | 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.
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 | 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 | 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 | 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 |
| Urinary tract infections | Urinary tract infections incidence rate | 7 days |
| Infections | Infections incidence rate | 7 days |
| All-cause mortality | All-cause mortality incidence rate | 90 days |
| Inpatient days | Total inpatient days | 90 days |
| 7 days |
| Dizziness within 7 days | Number of subjects who have dizziness within 7 days | 7 days |
| Nausea within 7 days | Number of subjects who have nausea within 7 days | 7 days |
| Palpitations within 7 days. | Number of subjects who have palpitations within 7 days. | 7 days |
| Background |
| Kalra 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. |
| 27733675 | Background | Hoffmann 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. |
| 22664787 | Background | Chamorro 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. |
| 21738161 | Background | Iadecola 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. |
| 17255542 | Background | Chamorro 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. |
| 25176179 | Background | Randhawa 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. |
| 41102804 | Derived | Jia 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |