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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

From: Induced neuroprotection by remote ischemic perconditioning as a new paradigm in ischemic stroke at the acute phase, a systematic review

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
RESCUE-BRAIN [15, 20]
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
  1. Abbreviations: bFGF Basic fibroblast growth factor, DWI Diffusion weighted imaging, GTAIS Guideline of thrombolysis in Acute Ischemic Stroke, MCA Middle cerebral artery, MRI Magnetic resonance imaging, mRS Modified Rankin Scale (mRS) Score, NIHSS National institute of Health Stroke Scale, PreSS Prehospital Stroke score, PWI-DWI Perfusion-weighted imaging-diffusion-weighted imaging, RACE Rapid arterial occlusion evaluation scale, RIC Remote ischaemic conditioning, RLIC Remote limb ischemic conditioning, rt-PA Recombinant tissue plasminogen activator, VEGF Vascular endothelial growth factor
  2. aRegistered in ISRCTN
  3. bRegistered in Netherlands Trial Register