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Protective Effects of RIC in Elderly With Acute Ischemic Stroke Complicating Acute Coronary Syndrome (RIC-ACS)

Primary Purpose

Elderly Patients, Acute Ischemic Stroke, Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RIC
sham-RIC
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Elderly Patients focused on measuring remote ischemic conditioning, elderly, acute ischemic stroke, Acute Coronary Syndrome

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xuanwu Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RIC group

sham-RIC group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the proportion of patients achieving functional independence
Functional independence is defined as modified Ranks scale [mRS] ≤2 points
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.
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.
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
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.

Full Information

First Posted
March 6, 2019
Last Updated
November 24, 2022
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03868007
Brief Title
Protective Effects of RIC in Elderly With Acute Ischemic Stroke Complicating Acute Coronary Syndrome
Acronym
RIC-ACS
Official Title
Protective Effects of Remote Ischemic Conditioning in Elderly With Acute Ischemic Stroke Complicating Acute Coronary Syndrome: A Single-center Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2019 (Actual)
Primary Completion Date
January 8, 2022 (Actual)
Study Completion Date
April 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Patients, Acute Ischemic Stroke, Acute Coronary Syndrome
Keywords
remote ischemic conditioning, elderly, acute ischemic stroke, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIC group
Arm Type
Experimental
Arm Description
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.
Arm Title
sham-RIC group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
RIC
Intervention Description
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
Intervention Name(s)
sham-RIC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Major adverse cardiac and cerebrovascular events (MACCEs)
Description
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
Secondary Outcome Measure Information:
Title
the proportion of patients achieving functional independence
Description
Functional independence is defined as modified Ranks scale [mRS] ≤2 points
Time Frame
from baseline to 3 months after therapy
Title
the national institutes of health stroke (NIHSS) score
Description
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
Title
plasma hypersensitive C-reactive protein（hs-CRP） level
Description
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
Title
global registry of acute coronary events (GRACE) score
Description
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
Title
modified Rankin scale（mRs）
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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