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Remote Ischemic Conditioning in Acute Ischemic Cerebral Vascular Disease Patients With Coexistence of Cerebral and Coronary Atherosclerosis（RIC-CCCA）

Primary Purpose

Acute Ischemic Cerebral Vascular Disease

Status

Enrolling by invitation

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

RIC

About this trial

This is an interventional prevention trial for Acute Ischemic Cerebral Vascular Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who suffered an ischemic stroke within 14 days prior to enrollment
With a baseline NIHSS score 0-15, mRS score 2-4
With at least one cerebral and carotid artery stenosis over 50%
With at least one coronary artery stenosis over 50% or previous myocardial ischemic events history(tertiary hospital doctors judge angina, myocardial infarction, and coronary revascularization treatment)
Age from 18 to 80
Informed consent obtained

Exclusion Criteria:

Thrombolytic therapy within 24 h prior to enrollment
Progressive neurological signs within 24 h prior to enrollment
Arterial stenosis due to unequivocal cardiac source of embolism, arterial dissection, vasculitic disease, cerebral venous thrombosis, Moyamoya disease
Arterial stenosis due to benign angiopathy of central nervous system, post-partum angiopathy, suspected vasospastic process, suspected recanalized embolus, neurosyphilis, any other intracranial infection
Rheumatic mitral disease with or without aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis
Uncontrolled severe hypertension, defined by sitting systolic blood pressure(SBP) > 180 mm Hg and/or sitting diastolic blood pressure(DBP) > 110 mm Hg after medication
Contraindication for remote ischemic conditioning, including severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs
Subclavian arterial stenosis 50% or subclavian steal syndrome
Severe hemostatic disorder or severe coagulation dysfunction, platelets < 100 ×10^9/L
Aspartate aminotransferase(AST) and/or Alanine aminotransferanse(ALT) > 3× the upper limit of the reference range; creatinine clearance < 0.6 mL/s and/or serum creatinine > 265 mmol/L (>3.0 mg/dL)
Unwilling to comply with the treatment or follow-up assessments
Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, or epidural) within 90 days prior to enrollment
Intracranial neoplasm, cerebral aneurysm, or arteriovenous malformation
Retinal hemorrhage or visceral bleeding within 30 days prior to enrollment
Major surgery, including cardiac and open femoral, aortic, or carotid surgery, within 30 days prior to enrollment or intent to undergo within 12 months after enrollment
Life expectancy < 3 years

Sites / Locations

Xuanwu Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RIC group

non-RIC group

Arm Description

The patients will accept cardio-cerebrovascular disease secondary prevention treatment and use RIC everyday for three months, 5 cycles 5min ischemic-5min reperfusion each day.

The patients will only accept cardio-cerebrovascular disease secondary prevention treatment.

Outcomes

Primary Outcome Measures

Complex ischemic cardio-cerebrovascular events cumulative incidence

include non-fatal acute ischemic cerebral vascular disease, non-fatal acute coronary syndrome, cardio-cerebrovascular events lead to death, elective cardio-cerebralvascular revascularization, myocardial and cerebral ischemia lead to hospitalize

Secondary Outcome Measures

Primary Outcome Events Occur

The first time of the primary outcome events occur

Rate of all-cause death

One year all-cause death rate

Score of Modified Rankin Scale(mRS)

The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). We will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator at 3 months. The distribution of mRS will be compared between groups

Full Information

NCT ID

NCT03721692

First Posted

October 22, 2018

Last Updated

October 30, 2018

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03721692

Brief Title

Remote Ischemic Conditioning in Acute Ischemic Cerebral Vascular Disease Patients With Coexistence of Cerebral and Coronary Atherosclerosis（RIC-CCCA）

Official Title

Remote Ischemic Conditioning in Acute Ischemic Cerebral Vascular Disease Patients With Coexistence of Cerebral and Coronary Atherosclerosis（RIC-CCCA）

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Enrolling by invitation

Study Start Date

January 17, 2018 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Remote ischemic conditioning(RIC) is a protective systemic strategy by organs brief and sublethal ischemia to confer protection from subsequent severe ischemia in distant organs, especially for heart and brain. This study will discuss whether RIC can play a part in preventing the patients with coexistence of cerebral and coronary atherosclerosis from the recurrence of cerebral vascular disease(CVD) or coronary artery disease(CAD). This study selects patients who suffered an ischemic stroke within 14 days prior to enrollment. All patients complete cerebral and coronary artery assessment. And then the the investigators select the patients who both have at least one cerebral vascular and at least one coronary artery stenosis over 50%, or the patients who both have at least one cerebral vascular stenosis over 50% and myocardial ischemic events history. These patients will randomly divide into two groups, RIC group and non-RIC group. Non-RIC group will only accept cardio-cerebrovascular disease secondary prevention treatment. RIC group will use not only cardio-cerebrovascular disease secondary prevention treatment, but also RIC everyday for three months, 5 cycles 5min ischemic-5min reperfusion each day. For the first month, the the investigators will call RIC group patients every week for insuring compliance and adverse effect. All patients will follow up endpoint events, cardio-cerebrovascular disease secondary prevention treatment, and the adverse effect every three months, up to one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Cerebral Vascular Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

392 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RIC group

Arm Type

Experimental

Arm Description

The patients will accept cardio-cerebrovascular disease secondary prevention treatment and use RIC everyday for three months, 5 cycles 5min ischemic-5min reperfusion each day.

Arm Title

non-RIC group

Arm Type

No Intervention

Arm Description

The patients will only accept cardio-cerebrovascular disease secondary prevention treatment.

Intervention Type

Device

Intervention Name(s)

RIC

Intervention Description

The patients will use RIC everyday for three months, 5 cycles 5min ischemic-5min reperfusion each day.

Primary Outcome Measure Information:

Title

Complex ischemic cardio-cerebrovascular events cumulative incidence

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Primary Outcome Events Occur

Description

The first time of the primary outcome events occur

Time Frame

1 year

Title

Rate of all-cause death

Description

One year all-cause death rate

Time Frame

1 year

Title

Score of Modified Rankin Scale(mRS)

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who suffered an ischemic stroke within 14 days prior to enrollment With a baseline NIHSS score 0-15, mRS score 2-4 With at least one cerebral and carotid artery stenosis over 50% With at least one coronary artery stenosis over 50% or previous myocardial ischemic events history(tertiary hospital doctors judge angina, myocardial infarction, and coronary revascularization treatment) Age from 18 to 80 Informed consent obtained Exclusion Criteria: Thrombolytic therapy within 24 h prior to enrollment Progressive neurological signs within 24 h prior to enrollment Arterial stenosis due to unequivocal cardiac source of embolism, arterial dissection, vasculitic disease, cerebral venous thrombosis, Moyamoya disease Arterial stenosis due to benign angiopathy of central nervous system, post-partum angiopathy, suspected vasospastic process, suspected recanalized embolus, neurosyphilis, any other intracranial infection Rheumatic mitral disease with or without aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis Uncontrolled severe hypertension, defined by sitting systolic blood pressure(SBP) > 180 mm Hg and/or sitting diastolic blood pressure(DBP) > 110 mm Hg after medication Contraindication for remote ischemic conditioning, including severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs Subclavian arterial stenosis 50% or subclavian steal syndrome Severe hemostatic disorder or severe coagulation dysfunction, platelets < 100 ×10^9/L Aspartate aminotransferase(AST) and/or Alanine aminotransferanse(ALT) > 3× the upper limit of the reference range; creatinine clearance < 0.6 mL/s and/or serum creatinine > 265 mmol/L (>3.0 mg/dL) Unwilling to comply with the treatment or follow-up assessments Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, or epidural) within 90 days prior to enrollment Intracranial neoplasm, cerebral aneurysm, or arteriovenous malformation Retinal hemorrhage or visceral bleeding within 30 days prior to enrollment Major surgery, including cardiac and open femoral, aortic, or carotid surgery, within 30 days prior to enrollment or intent to undergo within 12 months after enrollment Life expectancy < 3 years

Facility Information:

Facility Name

Xuanwu Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

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Remote Ischemic Conditioning in Acute Ischemic Cerebral Vascular Disease Patients With Coexistence of Cerebral and Coronary Atherosclerosis（RIC-CCCA）

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