Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke (REVISE-1)
|ClinicalTrials.gov Identifier: NCT03210051|
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : December 22, 2017
Currently, early reperfusion is considered as the most effective therapy for the treatment of acute ischemic stroke (AIS). Over the past 20 years, intravenous tissue plasminogen activator (IV tPA) has been demonstrated to be the only effective therapy for AIS. More recently, several large randomized clinical trials have concluded the superiority of endovascular mechanical thrombectomy for AIS. Furthermore, with the development of materials and techniques, the occluded artery can be recanalized with high percentage (60%-90%), and the rate of recanalization is still being improved. A great number of AIS patients are now eligible for revascularization therapy and there should be a good prognosis of AIS after recanalizing the occluded artery using mechanical thrombectomy. However, things are never as simple as wished to be. The rate of patients with functional independence is less than 50% and over 15% patients died at 3 months post thrombectomy. The discrepancy between the functional outcome and recanalization rates encourage researchers to explore strategies that further improving the functional outcome of AIS patients.
Remote ischemic conditioning has been demonstrated to reduce cerebral infarct size in mouse model of focal cerebral ischemia. And clinical researches demonstrated the protective effects of remote ischemic conditioning in AIS patient treated with IV tPA,. However, whether remote ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic stroke and undergoing endovascular treatment is still unknown.
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke||Device: Remote ischemic conditioning Procedure: Endovascular treatment||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||A Pilot Study Assessing the Safety and Feasibility of Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke|
|Actual Study Start Date :||July 7, 2017|
|Actual Primary Completion Date :||September 17, 2017|
|Actual Study Completion Date :||December 20, 2017|
Experimental: RIC & ET
Remote ischemic conditioning paired with endovascular treatment. RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times. Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association. It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.
Device: Remote ischemic conditioning
RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
Other Name: RIC
Procedure: Endovascular treatment
Endovascular treatment include strategies that used to recanalize the occluded artery. Strategies often used include thrombectomy, intra-arterial thrombolysis, stenting and balloon angiography.
Other Name: ET
- Number of participants with any RIC-related adverse events. [ Time Frame: 0-90 days after endovascular treatment. ]For all participants, adverse events will be assessed by as assessed by CTCAE v4.0.
- Change in cerebral artery blood flow velocity [ Time Frame: 0-7 days. ]Cerebral artery blood flow velocity is recorded continuously by Transcranial Doppler (TCD) during remote ischemic conditioning.
- Change in vital signs [ Time Frame: 0-7 days. ]Vital signs are documented continuously during remote ischemic conditioning.
- Change in intracranial pressure [ Time Frame: 0-7 days. ]Intracranial pressure is monitored by noninvasive intracranial pressure monitoring equipment during remote ischemic conditioning
- Change in plasma biomarkers [ Time Frame: 0-7 days. ]Plasma biomarkers include biochemical biomarkers (e.g.,creatine kinase), blood routine test and coagulation function (e.g., PT, APTT, TT).
- Final cerebral infarct volume. [ Time Frame: 5-9 days after endovascular treatment. ]The final infarct volume of cerebral infarct is evaluated by cranial noncontrast CT.
- Number of subjects completing all the designed RIC procedures. [ Time Frame: 0-7 days. ]9 times (36 cycles) of RIC interventions are planned to be applied to each subject pre and post-endovascular treatment for 7 consecutive days.
- The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS). [ Time Frame: 0-90 days. ]The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
- Symptomatic Intracerebral Hemorrhage. [ Time Frame: 0-90 days. ]Deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of hemorrhage in imaging scans.
- Any adverse event. [ Time Frame: 0-90 days. ]Adverse events related or not related to remote ischemic conditioning will be documented.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210051
|Xuanwu Hospital, Capital Medical University|
|Beijing, China, 100053|