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Status unknownNCT03721692Updated Oct 31, 2018

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

An interventional study of RIC in Acute Ischemic Cerebral Vascular Disease, sponsored by Capital Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-31.

Sponsored by Capital Medical University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2018, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
392
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's planned enrollment of 392 is above the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
392 participants (estimated)

Study arms

  • Experimental
    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.

    Device: RIC

  • No intervention
    non-RIC group

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

Interventions

  • DeviceRIC

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

06

What researchers measure

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

    Time frame: 1 year

Secondary outcomes

  1. Primary Outcome Events Occur

    The first time of the primary outcome events occur

    Time frame: 1 year

  2. Rate of all-cause death

    One year all-cause death rate

    Time frame: 1 year

  3. 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

    Time frame: 3 months

07

Study locations

1 site
  • Xuanwu Hospital, Capital Medical University
    Beijing, Beijing 100053, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03721692
Lead sponsor
Capital Medical University
Responsible party
Ji Xunming,MD,PhD (Principal Investigater, Capital Medical University) — Principal investigator
First posted
Oct 26, 2018
Start date
Jan 17, 2018
Primary completion
Jul 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Oct 31, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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