Remote ischemic conditioning (RIC)
DeviceRIC is a non-invasive therapy which is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol include five cycles of 5-min inflation to 200mmHg and 5-min deflation.
NCT Number: NCT04915313
This study intends to further reveal the antihypertensive effect of LRIC and explore its potential mechanisms.
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Notify Me50 year–80 year
All sexes
Interventional
Not applicable
Peking University Care Health Management Center, Beijing, Beijing Municipality, China
Stroke is the second-leading cause of death in the world and the leading cause of death in China. The estimated lifetime risk of stroke for those aged 25 years old and above is 24.9% worldwide and 39.3% in China. Hypertension is one of the main independent risk factors for stroke. Studies have shown that the risk of stroke increase at blood pressure (BP) above 115/75mmHg, each increase of 20mmHg in systolic blood pressure (SBP) or 10 mmHg in diastolic blood pressure (DBP) will double the risk of stroke. For those hypertensive patients without complications, each reduction of 10mmHg in SBP reduces approximately 17% risk of stroke, and each reduction of 5mmHg in DBP reduces 20%. Therefore, enhancing the primary prevention of stroke in hypertensive patients without vascular complications is important to reduce the burden of stroke in the future. However, these patients do not pay enough attention to their elevated BP and have poor compliance with antihypertensive drugs. Therefore, it is necessary to explore an economical, convenient and effective non-pharmacological therapy to control BP in order to reduce the risk of stroke.
Limb remote ischemic conditioning (LRIC) triggers endogenous protective effect through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of autonomic nervous system, release of humoral factors, improvement of vascular endothelial function and modulation of immune/inflammatory responses, which can antagonize the pathogenesis of hypertension through multiple pathways to lead a drop in BP theoretically. This theory has been preliminarily confirmed by several small sample-size studies. Therefore, this study intends to conduct a randomized controlled trial to further reveal the antihypertensive effect of LRIC and explore its potential mechanisms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RIC is a non-invasive therapy which is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol include five cycles of 5-min inflation to 200mmHg and 5-min deflation.
The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.
Time frame: From baseline to 4 weeks.
Changes of average 24-h ambulatory systolic blood pressure from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Changes of average 24-h ambulatory diastolic blood pressure from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Changes of average daytime ambulatory systolic blood pressure from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Changes of average daytime ambulatory diastolic blood pressure from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Changes of average night-time ambulatory systolic blood pressure from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Changes of average night-time ambulatory diastolic blood pressure from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Changes of average 24-h heart rate from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Proportion of patients with average 24-h ambulatory systolic blood pressure reduction more than 5 mmHg.
Time frame: From baseline to 4 weeks.
Changes of office systolic blood pressure from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Changes of office diastolic blood pressure from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Changes of FMD or ba-PWV from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Changes of blood biomarkers which have been demonstrated to correlate with hypertension, such as NO、ET-1、IL-10、TNF-α、IL-1β、SDF-1α, from baseline to four weeks.
Time frame: From baseline to 4 weeks.
Adverse events related to RIC treatment, such as local edema, erythema, skin lesions of the arms, or adverse events not related to RIC treatment.
Capital Medical University
Other
The Antihypertensive Effect of Remote Ischemic Conditioning: A Multicenter, Randomized, Double-blind, Sham-controlled Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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