An interventional study of remote ischemic conditioning and Sham treatment in Unruptured Intracranial Aneurysm and Infarction Cerebral, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Prevention
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.
219 studies on the registry are indexed under Cerebral Infarction; 46 are open to participants now.
This study's planned enrollment of 84 is below the median of 120 across 139 interventional studies indexed under Cerebral Infarction.
Browse Cerebral Infarction studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.
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Exclusion Criteria:
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.
Procedure: remote ischemic conditioning
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.
Procedure: Sham treatment
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.
Also known as: RIC
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.
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.
Time frame: Within 24 hours after the procedure,
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.
Time frame: One month after the procedure
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.
Time frame: 24 hours, 2 weeks, and 1 month postoperatively
The incidence of skin damage or bruising in the RIC group.
Time frame: before surgery and 24 hours, 2 weeks, and 1 month postoperatively
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University →