An interventional study of RIC and sham-RIC in Elderly Patients, Acute Ischemic Stroke and Acute Coronary Syndrome, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Capital Medical University · Not applicable, Interventional, and Prevention
Remote ischemic conditioning (RIC) is a noninvasive strategy in which one or more cycles of brief and transient limb ischemia confers protection against prolonged and severe ischemia in distant organs.This study aimed to investigate whether RIC is safe and effective in patients with AIS complicating ACS
Remote ischemic conditioning (RIC) is a noninvasive strategy in which one or more cycles of brief and transient limb ischemia confers protection against prolonged and severe ischemia in distant organs (e.g., brain and heart).It has been demonstrated to be an effective strategy to reduce plasma myocardial enzyme, infarct volume, and incidence of post-ACS heart failure in patients with ACS. Additionally, recent studies have found that RIC was safe and feasible in patients with AIS even in those caused by large artery occlusion and treated with reperfusion therapy, and it might benefit AIS patients by reducing the risk of brain tissue infarction and improving functional outcomes. To date, however, it is still unknow whether RIC, a systematic protective strategy, could benefit patients with AIS complicating ACS.This study aimed to investigate whether RIC is safe and effective in patients with AIS complicating ACS.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 80 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
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Exclusion Criteria:
Patients with AIS complicating ACS who were eligible for this study received standardized medical treatment and secondary prevention, including antiplatelets, low molecular weight heparin for anticoagulation，statins for lipid-lowering and stabilizing plaque, nitrates for vascular expansion and cardiocerebrovascular risk factors management. Administration of antihypertensive, antidiabetic or other agents were elective at the discretion of the treating physician according to the conditions of the patients. In addition, patients underwent RIC twice daily for 14 days.And the RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
Device: RIC
Patients with AIS complicating ACS who were eligible for this study received standardized medical treatment and secondary prevention, including antiplatelets, low molecular weight heparin for anticoagulation，statins for lipid-lowering and stabilizing plaque, nitrates for vascular expansion and cardiocerebrovascular risk factors management. Administration of antihypertensive, antidiabetic or other agents were elective at the discretion of the treating physician according to the conditions of the patients. In addition, patients underwent sham-RIC twice daily for 14 days.And the sham-RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
Device: sham-RIC
The RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
The sham-RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
Major adverse cardiac and cerebrovascular events (MACCEs)
MACCEs defined as all cause of death and recurrence of cardiac and cerebrovascular ischemic events within 3 months after randomization
Time frame: from baseline to 3 months after therapy
the proportion of patients achieving functional independence
Functional independence is defined as modified Ranks scale \[mRS\] ≤2 points
Time frame: from baseline to 3 months after therapy
the national institutes of health stroke (NIHSS) score
National Institute of Health Stroke Scale (NIHSS) is considered as a standardized assessment of neurological functions in the acute phase of stroke, and it is generally used to quantify patient's neurological impairments on 15 items in 11 fields of different neurological status.The score of the scale ranges from 0 to 42.And higher score indicates worse neurological function.The NHISS will be assessed by certified study investigator, who is blinded to the treatment assignment.
Time frame: changes from baseline to 7 days, 14 days ,30 days, 90 days after therapy
plasma hypersensitive C-reactive protein（hs-CRP） level
Blood samples were drawn from the cubital vein after enrolling into this study and two weeks after randomization. These samples were centrifuged immediately collection, and serum hs-CRP level were examined in fresh plasma samples.
Time frame: changes from baseline to 2 weeks after therapy
global registry of acute coronary events (GRACE) score
For each patient, GRACE score was calculated by using specific variables collected at admission. Patients were classified into 3 categories low (1-108), intermediate (109-140), and high (\>140), according to the GRACE score
Time frame: changes from baseline to 7 days, 14 days ,30 days, 90 days after therapy
modified Rankin scale（mRs）
this scale is to evaluate the neurological function，it ranges form 0 to 6, the lower score means better neurological outcome.
Time frame: changes from baseline to 7 days, 14 days ,30 days, 90 days after therapy
Plan to share: Undecided
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Capital Medical University