Acute Ischemic Cerebral Vascular DiseaseNCT03721692
Remote Ischemic Conditioning in Acute Ischemic Cerebral Vascular Disease Patients With Coexistence of Cerebral and Coronary Atherosclerosis（RIC-CCCA）
A study testing RIC in people with Acute Ischemic Cerebral Vascular Disease, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Cerebral Vascular Disease
- What is being tested?
- RIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2018to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
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
- Being tested
- RIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICDevice
The patients will use RIC everyday for three months, 5 cycles 5min ischemic-5min reperfusion each day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RIC |
| non-RIC group | No intervention | The patients will only accept cardio-cerebrovascular disease secondary prevention treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Primary Outcome Events Occur
The first time of the primary outcome events occur
Measured: 1 year
Rate of all-cause death
One year all-cause death rate
Measured: 1 year
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start17 Jan 2018
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Cerebral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721692
- Sponsor's protocol ID
- RIC-CCCA
- Status last verified
- Mar 2018
- First submitted
- 22 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning in Acute Ischemic Cerebral Vascular Disease Patients With Coexistence of Cerebral and Coronary Atherosclerosis（RIC-CCCA）
- ClinicalTrials.gov ID
- NCT03721692
- Acronym / sponsor ID
- RIC-CCCA
- Conditions
- Acute Ischemic Cerebral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: RICThe patients will accept cardio-cerebrovascular disease secondary prevention treatment and use RIC everyday for three months, 5 cycles 5min ischemic-5min reperfusion each day. |
| non-RIC group | No intervention | –The patients will only accept cardio-cerebrovascular disease secondary prevention treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RICThe patients will use RIC everyday for three months, 5 cycles 5min ischemic-5min reperfusion each day. | Device | RIC group |
Primary outcome
Complex ischemic cardio-cerebrovascular events cumulative incidence
Time frame: 1 year
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
3 secondary outcomes
Primary Outcome Events Occur
Time frame: 1 year
Rate of all-cause death
Time frame: 1 year
Score of Modified Rankin Scale(mRS)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIC in people with Acute Ischemic Cerebral Vascular Disease, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complex ischemic cardio-cerebrovascular events cumulative incidence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.