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

NCT03868007 | Completed

• 1 other identifier: RIC-ACS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Elderly Patients; Acute Ischemic Stroke; Acute Coronary Syndrome

Keywords

remote ischemic conditioning; elderly; acute ischemic stroke; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

  from baseline to 3 months after therapy

Secondary Outcomes (5)

• the proportion of patients achieving functional independence

  from baseline to 3 months after therapy

• the national institutes of health stroke (NIHSS) score

  changes from baseline to 7 days, 14 days ,30 days, 90 days after therapy

• plasma hypersensitive C-reactive protein（hs-CRP） level

  changes from baseline to 2 weeks after therapy

• global registry of acute coronary events (GRACE) score

  changes from baseline to 7 days, 14 days ,30 days, 90 days after therapy

• modified Rankin scale（mRs）

  changes from baseline to 7 days, 14 days ,30 days, 90 days after therapy

Study Arms (2)

RIC group

EXPERIMENTAL

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

sham-RIC group

SHAM COMPARATOR

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

Interventions

RIC 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.

RIC group

sham-RIC 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.

sham-RIC group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• 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.

  PMID: 38167175 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The RIC and sham procedure were performed by using identical devices with different cuff pressures (200mmHg versus 60 mmHg). Patients, investigators, and raters were all blinded to the treatment assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 8, 2019
• Study Start: March 10, 2019
• Primary Completion: January 8, 2022
• Study Completion: April 10, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CN (1)