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

NCT ID: NCT03721692

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-17
• Study Completion Date: 2024-12-31

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.

Conditions

Acute Ischemic Cerebral Vascular Disease

Study Design

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

Study Groups

RIC group

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.

Group Type: EXPERIMENTAL

RIC

Intervention Type: DEVICE

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

non-RIC group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RIC

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients who suffered an ischemic stroke within 14 days prior to enrollment

2. With a baseline NIHSS score 0-15, mRS score 2-4

3. With at least one cerebral and carotid artery stenosis over 50%

4. 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)

5. Age from 18 to 80

6. Informed consent obtained

Exclusion Criteria

1. Thrombolytic therapy within 24 h prior to enrollment

2. Progressive neurological signs within 24 h prior to enrollment

3. Arterial stenosis due to unequivocal cardiac source of embolism, arterial dissection, vasculitic disease, cerebral venous thrombosis, Moyamoya disease

4. Arterial stenosis due to benign angiopathy of central nervous system, post-partum angiopathy, suspected vasospastic process, suspected recanalized embolus, neurosyphilis, any other intracranial infection

5. 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

6. 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

7. Contraindication for remote ischemic conditioning, including severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs

8. Subclavian arterial stenosis 50% or subclavian steal syndrome

9. Severe hemostatic disorder or severe coagulation dysfunction, platelets < 100 ×10^9/L

10. 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)

11. Unwilling to comply with the treatment or follow-up assessments

12. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, or epidural) within 90 days prior to enrollment

13. Intracranial neoplasm, cerebral aneurysm, or arteriovenous malformation

14. Retinal hemorrhage or visceral bleeding within 30 days prior to enrollment

15. 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

16. Life expectancy < 3 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Principal Investigater

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

RIC-CCCA

Identifier Type: -

Identifier Source: org_study_id