Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to explore the efficacy of ischemic conditioning treatment, performed preoperatively and postoperatively, in reducing procedure-related microembolic infarctions during standard stent-assisted aneurysm coiling. The primary outcomes include the incidence of acute microembolic infarctions postoperatively and the incidence of symptomatic microembolic infarctions at one month following RIC.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC | Experimental | All enrolled patients receive standard stent-assisted aneurysm coiling therapy(Patients are required to receive antiplatelet therapy for at least 3 days before the procedure, consisting of:Aspirin: 100 mg once daily, combined with Clopidogrel: 75 mg once daily, or Ticagrelor: 90 mg twice daily).Depending on intraoperative and postoperative conditions, tirofiban is administered as follows: an initial bolus of 0.6 μg/kg over 3 minutes, followed by continuous intravenous infusion at 0.1 μg/kg/min for 18 hours. Remote ischemic conditioning (RIC) is applied to the contralateral upper limb, consisting of 5 cycles per session, 2 sessions per day. Each cycle includes 5 minutes of ischemia followed by 5 minutes of reperfusion. The pressure used to occlude the brachial artery is set at 200 mmHg or exceeds baseline systolic pressure by 35 mmHg At least 4 sessions of actual RIC treatment before the procedure.Continued RIC treatment for a minimum of 4 weeks postoperatively. |
|
| sham | Sham Comparator | All enrolled patients receive standard stent-assisted aneurysm coiling therapy.(Patients are required to receive antiplatelet therapy for at least 3 days before the procedure, consisting of:Aspirin: 100 mg once daily, combined with Clopidogrel: 75 mg once daily, or Ticagrelor: 90 mg twice daily).Depending on intraoperative and postoperative conditions, tirofiban is administered as follows: an initial bolus of 0.6 μg/kg over 3 minutes, followed by continuous intravenous infusion at 0.1 μg/kg/min for 18 hours. Remote ischemic conditioning (RIC) is applied to the contralateral upper limb, consisting of 5 cycles per session, 2 sessions per day. Each cycle includes 5 minutes of ischemia followed by 5 minutes of reperfusion. The pressure used to occlude the brachial artery is set at 20 mmHg. At least 4 sessions of sham RIC treatment before the procedure.Continued sham RIC treatment for a minimum of 4 weeks postoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote ischemic conditioning | Procedure | Remote ischemic conditioning (RIC) is applied to the contralateral upper limb, consisting of 5 cycles per session, 2 sessions per day. Each cycle includes 5 minutes of ischemia followed by 5 minutes of reperfusion. The pressure used to occlude the brachial artery is set at 200 mmHg or exceeds baseline systolic pressure by 35 mmHg (intervention group).At least 4 sessions of actual RIC treatment before the procedure.Continued RIC treatment for a minimum of 4 weeks postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Remote Ischemic Conditioning (RIC) in Preventing Small Infarctions Associated with Stent-Assisted Aneurysm Coiling | Within 24 hours after the procedure, a brain MRI is performed to record the number and size of hyperintense signals on DWI. The trial group and control group are compared, and the efficacy is assessed based on statistical analysis results. If the mean number of hyperintense signals on DWI in the trial group is lower than that in the control group, with a statistically significant difference, the intervention is considered effective; otherwise, it is considered ineffective. | Within 24 hours after the procedure, |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Chronic Remote Ischemic Conditioning (RIC) in Treating Small Infarctions Associated with Stent-Assisted Aneurysm Coiling | One month after the procedure, a follow-up brain MRI is performed to evaluate the infarct area and number based on the size and number of hyperintense signals observed on DWI at 24 hours postoperatively. Additionally, the modified Rankin Scale (mRS) is completed one month postoperatively. The trial group and control group are compared, and efficacy is assessed based on statistical analysis results. If the mean infarct area and number in the trial group are lower than those in the control group, with statistically significant differences, the intervention is considered effective; otherwise, it is deemed ineffective. Similarly, if the mRS score distribution in the trial group is lower than that in the control group, with statistically significant differences, the intervention is considered effective; otherwise, it is considered ineffective. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of thrombus formation or embolic events in the limb subjected to RIC in the intervention group. | Vascular ultrasound of the limb subjected to RIC will be performed at 24 hours, 2 weeks, and 1 month postoperatively to assess for thrombus formation or thromboembolism. | 24 hours, 2 weeks, and 1 month postoperatively |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifei Wang | Contact | +86-13852665323 | wangyifei5323@163.com |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30942660 | Background | Mohammad Seyedsaadat S, Rangel Castilla L, Lanzino G, Cloft HJ, Blezek DJ, Theiler A, Kadirvel R, Brinjikji W, Kallmes DF. Remote ischemic preconditioning for elective endovascular intracranial aneurysm repair: a feasibility study. Neuroradiol J. 2019 Jun;32(3):166-172. doi: 10.1177/1971400919842059. Epub 2019 Apr 3. | |
| 28174194 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Standard Treatment All enrolled patients receive standard stent-assisted aneurysm coiling therapy. Depending on intraoperative and postoperative conditions, tirofiban is administered as follows: an initial bolus of 0.6 μg/kg over 3 minutes, followed by continuous intravenous infusion at 0.1 μg/kg/min for 18 hours.
RIC Treatment Protocol Remote ischemic conditioning (RIC) is applied to the contralateral upper limb, consisting of 5 cycles per session, 2 sessions per day. Each cycle includes 5 minutes of ischemia followed by 5 minutes of reperfusion. The pressure used to occlude the brachial artery is set at 200 mmHg or exceeds baseline systolic pressure by 35 mmHg (intervention group) or 20 mmHg (control group).
Group Assignments
Group A (Control Group):
At least 4 sessions of sham RIC treatment before the procedure. Continued sham RIC treatment for a minimum of 4 weeks postoperatively.
Group B (Intervention Group):
At least 4 sessions of actual RIC treatment before the procedure. Cont
Not provided
Not provided
Not provided
Not provided
|
|
| Sham treatment | Procedure | Remote ischemic conditioning (RIC) is applied to the contralateral upper limb, consisting of 5 cycles per session, 2 sessions per day. Each cycle includes 5 minutes of ischemia followed by 5 minutes of reperfusion. The pressure used to occlude the brachial artery is set at 20 mmHg.At least 4 sessions of sham RIC treatment before the procedure.Continued sham RIC treatment for a minimum of 4 weeks postoperatively. |
|
| One month after the procedure |
| The incidence of skin damage or bruising in the RIC group. |
| before surgery and 24 hours, 2 weeks, and 1 month postoperatively |
| Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7. |
| 25956401 | Background | Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6. |
| 26630942 | Background | Laiwalla AN, Ooi YC, Liou R, Gonzalez NR. Matched Cohort Analysis of the Effects of Limb Remote Ischemic Conditioning in Patients with Aneurysmal Subarachnoid Hemorrhage. Transl Stroke Res. 2016 Feb;7(1):42-8. doi: 10.1007/s12975-015-0437-3. Epub 2015 Dec 2. |
| 29042490 | Background | Wang Y, Meng R, Song H, Liu G, Hua Y, Cui D, Zheng L, Feng W, Liebeskind DS, Fisher M, Ji X. Remote Ischemic Conditioning May Improve Outcomes of Patients With Cerebral Small-Vessel Disease. Stroke. 2017 Nov;48(11):3064-3072. doi: 10.1161/STROKEAHA.117.017691. Epub 2017 Oct 17. |
| 38299363 | Background | Blauenfeldt RA, Mortensen JK, Hjort N, Valentin JB, Homburg AM, Modrau B, Sandal BF, Gude MF, Berhndtz AB, Johnsen SP, Hess DC, Simonsen CZ, Andersen G. Effect of Remote Ischemic Conditioning in Ischemic Stroke Subtypes: A Post Hoc Subgroup Analysis From the RESIST Trial. Stroke. 2024 Apr;55(4):874-879. doi: 10.1161/STROKEAHA.123.046144. Epub 2024 Feb 1. |
| 26385956 | Background | Eitel I, Stiermaier T, Rommel KP, Fuernau G, Sandri M, Mangner N, Linke A, Erbs S, Lurz P, Boudriot E, Mende M, Desch S, Schuler G, Thiele H. Cardioprotection by combined intrahospital remote ischaemic perconditioning and postconditioning in ST-elevation myocardial infarction: the randomized LIPSIA CONDITIONING trial. Eur Heart J. 2015 Nov 21;36(44):3049-57. doi: 10.1093/eurheartj/ehv463. Epub 2015 Sep 17. |
| 23414904 | Background | Luo SJ, Zhou YJ, Shi DM, Ge HL, Wang JL, Liu RF. Remote ischemic preconditioning reduces myocardial injury in patients undergoing coronary stent implantation. Can J Cardiol. 2013 Sep;29(9):1084-9. doi: 10.1016/j.cjca.2012.11.022. Epub 2013 Feb 12. |
| 18456674 | Background | Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2. |
| 24060957 | Background | Bell R, Yellon D. Surgery: Remote ischaemic conditioning--approaching prime time? Nat Rev Cardiol. 2013 Nov;10(11):619-21. doi: 10.1038/nrcardio.2013.154. Epub 2013 Sep 24. No abstract available. |
| 26389009 | Background | Kim DY, Park JC, Kim JK, Sung YS, Park ES, Kwak JH, Choi CG, Lee DH. Microembolism after Endovascular Treatment of Unruptured Cerebral Aneurysms: Reduction of its Incidence by Microcatheter Lumen Aspiration. Neurointervention. 2015 Sep;10(2):67-73. doi: 10.5469/neuroint.2015.10.2.67. Epub 2015 Sep 2. |
| 26381257 | Background | Park JC, Lee DH, Kim JK, Ahn JS, Kwun BD, Kim DY, Choi CG. Microembolism after endovascular coiling of unruptured cerebral aneurysms: incidence and risk factors. J Neurosurg. 2016 Mar;124(3):777-83. doi: 10.3171/2015.3.JNS142835. Epub 2015 Sep 18. |
| 10560674 | Background | Bendszus M, Koltzenburg M, Burger R, Warmuth-Metz M, Hofmann E, Solymosi L. Silent embolism in diagnostic cerebral angiography and neurointerventional procedures: a prospective study. Lancet. 1999 Nov 6;354(9190):1594-7. doi: 10.1016/S0140-6736(99)07083-X. |
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided