scholarly journals Multi-Center Randomized Phase II Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies (TRICS-9): Study Design and Protocol

2021 ◽  
Vol 12 ◽  
Author(s):  
Susanna Diamanti ◽  
Simone Beretta ◽  
Mauro Tettamanti ◽  
Simona Sacco ◽  
Giuliano Sette ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Sample Size ◽  
Medical Therapy ◽  
Phase Ii ◽  
Remote Ischemic Conditioning ◽  
Ischemic Conditioning ◽  
Neurological Improvement ◽  
Standard Medical Therapy ◽  
Symptomatic Intracerebral Hemorrhage

Aim: To assess the efficacy of remote ischemic conditioning (RIC) in patients with ischemic stroke within 9 h of onset, that are not candidates for recanalization therapies.Sample Size Estimates: A sample size of 80 patients (40 in each arm) should yield 80% power to detect a 20% difference in early neurological improvement at 72 h at p = 0.05, two sided.Methods and Design: TRICS-9 is a phase II, multicenter, controlled, block randomized, open-label, interventional clinical trial. Patients recruited in Italian academic hospitals will be randomized 1:1 to either RIC plus standard medical therapy or standard medical therapy alone. After randomization, RIC will be applied manually by four alternating cycles of inflation/deflation 5 min each, using a blood pressure cuff around the non-paretic arm.Study Outcomes: The primary efficacy outcome is early neurological improvement, defined as the percent change in the National Institute of Health Stroke Scale (NIHSS) at 72 h in each arm. Secondary outcomes include early neurologic improvement at 24 and 48 h, disability at 3 months, rate of symptomatic intracerebral hemorrhage, feasibility (proportion of patients completing RIC), tolerability after RIC and at 72 h, blood levels of HIF-1α, and HSP27 at 24 h and 72 h.Discussion/Conclusion: RIC in combination with recanalization therapies appears to add no clinical benefit to patients, but whether it is beneficial to those that are not candidates for recanalization therapies is still to be demonstrated. TRICS-9 has been developed to elucidate this issue.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT04400981.

scholarly journals RIC in COVID-19—a Clinical Trial to Investigate Whether Remote Ischemic Conditioning (RIC) Can Prevent Deterioration to Critical Care in Patients with COVID-19

2021 ◽  
Author(s):  
Sean M. Davidson ◽  
Kishal Lukhna ◽  
Diana A. Gorog ◽  
Alan D. Salama ◽  
Alejandro Rosell Castillo ◽  
...  
Keyword(s):  
South Africa ◽  
Clinical Trial ◽  
United Kingdom ◽  
Inflammatory Cytokines ◽  
In Vitro Cytotoxicity ◽  
Cytokine Storm ◽  
Remote Ischemic Conditioning ◽  
Ischemic Conditioning ◽  
The United Kingdom

Abstract Purpose Coronavirus disease 19 (COVID-19) has, to date, been diagnosed in over 130 million persons worldwide and is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Several variants of concern have emerged including those in the United Kingdom, South Africa, and Brazil. SARS-CoV-2 can cause a dysregulated inflammatory response known as a cytokine storm, which can progress rapidly to acute respiratory distress syndrome (ARDS), multi-organ failure, and death. Suppressing these cytokine elevations may be key to improving outcomes. Remote ischemic conditioning (RIC) is a simple, non-invasive procedure whereby a blood pressure cuff is inflated and deflated on the upper arm for several cycles. “RIC in COVID-19” is a pilot, multi-center, randomized clinical trial, designed to ascertain whether RIC suppresses inflammatory cytokine production. Methods A minimum of 55 adult patients with diagnosed COVID-19, but not of critical status, will be enrolled from centers in the United Kingdom, Brazil, and South Africa. RIC will be administered daily for up to 15 days. The primary outcome is the level of inflammatory cytokines that are involved in the cytokine storm that can occur following SARS-CoV-2 infection. The secondary endpoint is the time between admission and until intensive care admission or death. The in vitro cytotoxicity of patient blood will also be assessed using primary human cardiac endothelial cells. Conclusions The results of this pilot study will provide initial evidence on the ability of RIC to suppress the production of inflammatory cytokines in the setting of COVID-19. Trial Registration NCT04699227, registered January 7th, 2021.

scholarly journals Remote Ischemic Conditioning for Preventing and Treating Ischemic Stroke

Stroke ◽  
2018 ◽  
Vol 49 (12) ◽  
Author(s):  
Wenbo Zhao ◽  
Jing Zhang ◽  
Mordechai Sadowsky ◽  
Ran Meng ◽  
Yuchuan Ding ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Remote Ischemic Conditioning ◽  
Ischemic Conditioning

scholarly journals Quality of Life in Physical, Social, and Cognitive Domains Improves With Endovascular Therapy in the DEFUSE 3 Trial

Stroke ◽  
2021 ◽  
Author(s):  
Laura C. Polding ◽  
William J. Tate ◽  
Michael Mlynash ◽  
Michael P. Marks ◽  
Jeremy J. Heit ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ischemic Stroke ◽  
Medical Therapy ◽  
Social Participation ◽  
Endovascular Therapy ◽  
Neurological Disorders ◽  
Measurement Tool ◽  
Modified Rankin Scale ◽  
Standard Medical Therapy

Background and Purpose: The DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3) randomized clinical trial demonstrated the efficacy of endovascular therapy in treating ischemic stroke 6 to 16 hours after onset, resulting in better functional outcomes than standard medical therapy alone. The objective of this secondary analysis is to analyze the effect of late-window endovascular treatment of ischemic stroke on quality of life (QoL) outcomes. Methods: Patients (n=182) who presented between 6 and 16 hours after they were last known to be well with acute anterior circulation ischemic stroke were randomized to endovascular thrombectomy plus standard medical therapy or standard medical therapy alone and followed-up through 90 days poststroke. QoL at day 90 was assessed with the QoL in Neurological Disorders measurement tool. Results: Of the 146 subjects alive at day 90, 136 (95%) filled out QoL in Neurological Disorders short forms. Patients treated with endovascular therapy had better QoL scores in each domain: mobility, social participation, cognitive function, and depression ( P <0.01 for all). Variables other than endovascular therapy that were independently associated with better QoL included lower baseline National Institutes of Health Stroke Scale, younger age, and male sex. The degree to which the modified Rankin Scale captures differences in QoL between patients varied by domain; the modified Rankin Scale score accounted for a high proportion of the variability in mobility (Rs 2 =0.82), a moderate proportion in social participation (Rs 2 =0.62), and a low proportion in cognition (Rs 2 =0.31) and depression (Rs 2 =0.19). Conclusions: Patients treated with endovascular therapy 6 to 16 hours after stroke have better QoL than patients treated with medical therapy alone, including better mobility, more social participation, superior cognition, and less depression. The modified Rankin Scale fails to capture patients’ outcomes in cognition and depression, which should therefore be assessed with dedicated QoL tools. REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02586415.

scholarly journals Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Ischemic Stroke

2020 ◽  
Vol Volume 16 ◽  
pp. 283-299
Author(s):  
Chen Qin ◽  
Xiuli Yan ◽  
Hang Jin ◽  
Ruyi Zhang ◽  
Yaode He ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Cerebral Hemodynamics ◽  
Remote Ischemic Conditioning ◽  
Ischemic Conditioning

scholarly journals Remote Ischemic Conditioning as an Additional Treatment for Acute Ischemic Stroke

Stroke ◽  
2019 ◽  
Vol 50 (7) ◽  
pp. 1934-1939 ◽  
Author(s):  
Thijs R.J. Landman ◽  
Yvonne Schoon ◽  
Michiel C. Warlé ◽  
Frank-Erik de Leeuw ◽  
Dick H.J. Thijssen
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Additional Treatment ◽  
Remote Ischemic Conditioning ◽  
Ischemic Conditioning
Sign in / Sign up

Export Citation Format

Share Document