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

NCT03721692 | Unknown

• 1 other identifier: RIC-CCCA
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (3)

• Primary Outcome Events Occur

  1 year

• Rate of all-cause death

  1 year

• Score of Modified Rankin Scale(mRS)

  3 months

Study Arms (2)

RIC group

EXPERIMENTAL

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.

Device: RIC

non-RIC group

NO INTERVENTION

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

Interventions

RIC DEVICE

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

RIC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigater

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 26, 2018
• Study Start: January 17, 2018
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 31, 2018

Record last verified: 2018-03

Locations

CN (1)