Protective Effects of RIC in Elderly With Acute Ischemic Stroke Complicating Acute Coronary Syndrome

NCT ID: NCT03868007

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-10
• Study Completion Date: 2022-04-10

Brief Summary

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

Detailed Description

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.

Conditions

Elderly Patients; Acute Ischemic Stroke; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

RIC group

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.

Group Type: EXPERIMENTAL

RIC

Intervention Type: DEVICE

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.

sham-RIC group

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.

Group Type: SHAM_COMPARATOR

sham-RIC

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

sham-RIC

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age≥60yo
• AIS within 24 hours after symptom onset which meet the diagnostic criteria for acute ischemic stroke of the 2013th ASA guidelines, AIS was defined as a clinical episode of neurological dysfunction caused by focal cerebral infarction that can be detected on imaging(e.g.,computed tomography or magnetic resonance imaging of head)
• ACS within 24 hours of stroke onset , and ACS contains ST-segment elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina and it was defined when there is a rise and/or fall of plasma cardiac biomarkers (e.g., myocardial enzyme，cardiac troponin I), along with supportive evidence in the form of typical symptoms (e.g., chest pain), suggestive electrocardiographic changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
• The patients missed the opportunity of or contradicted to reperfusion therapy (i.e., intravenous thrombolysis and endovascular treatments) for both AIS and ACS.
• Informed consent obtained

Exclusion Criteria

• Unstable vital signs
• Prior ipsilateral stroke with residual deficits
• AIS caused by cardioembolism, suspicious arterial dissection, intracranial sinus thrombolysis, vasculitis, and moyamoya disease.
• Intracranial bleeding.
• Advanced malignancy.
• Uncontrolled hypertension (defined as systolic blood pressure ≥200 mm Hg despite medications at enrollment).
• Any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated bilateral arm ischemic preconditioning.
• Peripheral vascular disease that affecting the upper limbs' arteries
• Any disorder that could potentially increase pre-stroke myocardial enzyme concentrations (eg, percutaneous coronary intervention or myocardial infarction within the previous 6 weeks)
• Coronary artery stenosis requiring coronary bypass surgery for the index event within 3 months; or severe heart failure requiring mechanical ventilation or use of an intra-aortic balloon pump
• Taking drugs in the study period or are participating in other clinical trials.
• Severe psychiatric disease.
• Patients who cannot keep treatment or follow-up.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

References

Li S, Xing X, Wang L, Xu J, Ren C, Li Y, Wang J, Liu Z, Zhao H, Zhao W, Ji X. Remote ischemic conditioning reduces adverse events in patients with acute ischemic stroke complicating acute myocardial infarction: a randomized controlled trial. Crit Care. 2024 Jan 2;28(1):5. doi: 10.1186/s13054-023-04786-y.

Reference Type: DERIVED

PMID: 38167175 (View on PubMed)

Other Identifiers

RIC-ACS

Identifier Type: -

Identifier Source: org_study_id