Table 1 Summary of characteristics of 19 clinical trials and research papers included in this systematic review on remote ischemic per-conditioning application on acute ischemic stroke patients
NTC Number Acronym/Ref | Country | Registered year | Estimated enrollment | Age | Criteria | Time before inclusion | Prehospital intervention | Application # cycles Pressure | Application of RIC | Intervention | Primary outcome measures | Recruitment status |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT0097596 [21] | Denmark | 2009 | 120 | > 18 | Ischemic stroke and rtPA therapy candidate, cerebral infarct showed on MRI | 4.5 h | Yes | Manual rIPerC, 4 × 5′ Up to 25 mmHg above systolic BP | Non-affected upper extremity | One time Control group: not RIC simulation | Difference in infarct growth (PWI-DWI) after 24 h (Salvage index) | Completed and published |
NCT02189928 | France | 2014 | 200 | > 18 | Carotid ischemic stroke, confirmed by MRI, NIHSS ≥5 and ≤ 25 | < 6 h | No | Device, 4 × 5′ 110 mmHg | Non-affected lower extremity | One time after initial MRI Control group: RIC simulation (no pressure) | Infarct volume by MRI at 24 h mRS at 90 days | Completed and published |
RECAST [17] | UK | 2015a | 26 | > 18 | Ischemic stroke with motor deficits on arm and/or leg | < 24 h | No | Manual RIC, 4 × 5′ Up to 20 mmHg above systolic BP | Non-affected upper extremity | One time Control group: manual RIC simulation (30 mmHg) | Tolerability and feasibility | Complete and published |
NCT03210051 REVISE-1 [18] | China | 2017 | 20 | 18–80 | Ischemic Stroke and endovascular recanalization | < 6 h | No | Device, 5 × 5′ 200 mmHg | Both upper extremities | One time No control group | Frequency of adverse events at 90 days | Completed |
NCT03231384 rtPA-RIC1 [19] | China | 2017 | 30 | >  18 | Confirmed Ischemic Stroke and rtPA therapy on going | < 4.5 h | No | Doctormate device, 5 × 5′ 200 mmHg | Both upper extremities | One time 2 h after rtPA therapy; twice daily for 6 days. Control group: not RIC simulation | Feasibility of RIC within 7 days | Completed |
NCT02779712 ReCAST-2 | UK | 2016 | 120 | > 18 | Ischemic stroke | 6 h | No | Manual, 4 × 5′ Up to 20 mmHg above systolic BP | Non-affected upper extremity | Group1: one time. Group2: two times (repetition after 60 min). Group3: twice daily for 4 days. Control group: manual RIC simulation (30 mmHg) | Trial feasibility at 90 days | Completed |
NCT02886390 rtPA-RIC | China | 2016 | 60 | 18–80 | Clinical sign and symptoms of acute ischemic stroke and rtPA therapy candidate, NIHSS score ≥ 4 and ≤ 15 | 4.5 h | No | Doctormate device, 5 × 5′ 200 mmHg | Both upper extremities | One time within 2 h after rtPA therapy Control group: not RIC simulation | Infarct volume Infarct volume by MRI at 72 h | Recruiting |
NCT03375762 REMOTE-CAT | Spain | 2017 | 572 | > 18 | Clinical signs and symptoms of acute ischemic stroke, RACE > 0, RACE motor > 0, known-onset stroke | < 8 h | Yes | Device, 5 × 5′, 200 mmHg | Non-affected upper extremity | One time in the ambulance Control group: RIC simulation (no pressure) | Infarct volume by MRI at 72 h mRS at 90 days | Recruiting |
NCT03218293 TRIPCAIS | China | 2017 | 120 | all | Confirmed ischemic stroke by neuroimaging, accordance with GTAIS and accomplish rtPA therapy | < 4.5 h | No | RIPC Device, 5 × 5’ | Non-affected upper extremity | One time after rtPA therapy Control group: not RIC simulation | VEGF and bFGF levels at 14 and 90 days | Recruiting |
NCT03045055 REVISE-2 | China | 2017 | 180 | 18–80 | Confirmed Ischemic Stroke, NIHSS ≥6, Endovascular recanalization | < 6 h | No | Device, 4 × 5′ 200 mmHg | Upper extremity | One time Control group: RIC simulation (60 mmHg) | Infarct volume at 3–7 days post-stroke | Not recruiting yet |
NCT03152799 RICE PAC | UK | 2017 | 60 | >  18 | Ischemic Stroke, proximal anterior occlusion, endovascular recanalization | < 6 h | No | Manual | Non-affected upper/lower extremity | One time Control group: RIC simulation | Infarct volume by MRI at 90 days | Not recruiting yet |
REPOST [16] | Netherlands | 2017b | 200 | > 18 | Ischemic stroke | < 12 h | No | Manual 4 × 5′ Up to 20 mmHg above systolic BP | Upper extremity | Twice daily ×  4 days Control group: twice daily ×  7 days (50 mmHg) | Infarct volume by MRI at 4 days | Recruiting |
NCT03669653 SERIC-AIS | China | 2018 | 912 | 18–80 | Confirmed Ischemic Stroke, NIHSS score > 5 and ≤ 25 | < 12 h | No | Device, 4 × 5′ 200 mmHg | Both upper extremities | Twice daily ×  7 days Control group: twice daily ×  7 days (60 mmHg) | mRS at 90 days | Recruiting |
NCT03740971 RICAMIS | China | 2018 | 1800 | >  18 | Confirmed Ischemic Stroke by neuroimaging, NIHSS score ≥ 6 and ≤ 16 | 48 h | No | – | – | Twice one day Control group: not RIC simulation | Neurological score at 90 days | Recruiting |
NCT03481777 RESIST [14] | Denmark | 2018 | 1500 | > 18 | Clinical signs and symptoms of stroke, PreSS ≥1 | < 4 h | Yes | Device, 5 × 5’, 200 mmHg | Non-affected upper extremity | Two times, one at the ambulance and one 6 h after in the hospital. Some patients get twice daily for 7 days. Control group: RIC simulation (20 mmHg) | mRS at 90 days | Recruiting |
NCT03481205 ICARUS | US | 2018 | 10 | 18–85 | Ischemic stroke, air transportation to a Stroke unit for endovascular recanalization, NIHSS ≥6 | – | No | Doctormate Device, 3–5 × 5′ 200 mmHg | Both upper extremities | One time in route (airplane) to Stroke center No control group | Feasibility of delivering RLIC by air medical crews | Not recruiting yet |
NCT04027621 SERICT-AIS | China | 2019 | 50 | 18–80 | Confirmed Ischemic Stroke and rtPA therapy, NIHSS score > 5 and ≤ 25 | – | No | Device, 4 × 5′ 200 mmHg | Non-affected upper extremity | Twice within 6–24 h from rtPA therapy, Control group: twice within 6–24 h from rtPA therapy (60 mmHg) | Frequency of adverse events at 7 days or earlier | Not recruiting yet |
NCT04069546 RIC-SIID | China | 2019 | 30 | >  18 | Confirmed Ischemic Stroke, NIHSS ≤15 | < 48 h | No | Device, 5 × 5′ 180 mmHg | Upper extremity | One time < 48 h from stroke symptom onset Control group: not RIC simulation | Plasma levels of mHLA-DR at 2 and 7 days, pneumonia incidence within 7 days | Not recruiting yet |
NCT03915782 PROTECT I | France | 2019 | 126 | >  18 | Ischemic Stroke, full occlusion of the MCA (occlusion of M1 and/or proximal M2), confirmed by MRA and DWI Endovascular recanalization | < 6 h | No | Device, 4 × 5′ 200 mmHg | Upper extremity | One time after first MRI Control group: RIC simulation (30 mmHg) | Infarct volume by MRI after 24 h from endovascular recanalization | Not recruiting yet |