Cerebral RevascularizationNCT03256513
The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization
A study of Cerebral Revascularization and Ischemic Cerebrovascular Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood flow monitoring and blood pressure, and combining patient demographics and preoperative risk factors to establish an applicable individual blood pressure controlling model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Revascularization, Ischemic Cerebrovascular Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,270 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2017to 1 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic patient with carotid artery stenosis>=50% or asymptomatic patient with carotid artery stenosis>=70%, according to DSA or CTA;
- without massive cerebral infarction(infarction area >1/2 territory of middle cerebral artery) confirmed by CT or MRI;
- informed consent acquired.
Who cannot join
- lesion beyond range limit of procedure (higher than C2);
- target vascular complete occlusion or ipsilateral intracranial artery severe stenosis or complete occlusion cannot be revascularized via CEA procedure
- nonatherosclerotic carotid stenosis, such as vasculitis, dissection, congenital vascular malformation;
- history of instable angina pectoris, myocardial infarction or congestive heart failure within 6 months unable to accept systematic anesthesia;
- history of severe injury, surgery or radiotherapy on neck;
- with comorbid hemorrhagic cerebral disease such as intracranial aneurysm or vascular malformation;
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- with comorbid blood system disease causing refractory coagulation dysfunction or rejection to blood or blood products perfusion;
- with other comorbidity, expected life < 2 years;
- severe diabetes mellitus difficult to control, blood sugar >300mg/dl;
- pregnancy or peri-natal period;
- intolerance to systematic anesthesia or surgery after adequate preparation.
- intolerance to peri-procedural drug possible to administrated;
- not cooperating or rejecting to informed consent;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of neurosurgery, Xuanwu hospital
Beijing, 100053
Liqun Jiao, MD, 86-10-83198899 ext. 8836, jiaoliqun@gmail.com
About this study
Official title: The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization for Ischemic Cerebral Vascular Disease
Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood flow monitoring and blood pressure, and combining patient demographics and preoperative risk factors to establish an applicable individual blood pressure controlling model. By comparing with routine antihypertensive strategies through prospective randomized controlled trials , to provide the best perioperative blood pressure control standards and strategies for each patient ,thus better ensuring the safety and efficacy of CEA .
- Being tested
- model controlling, conventional controlling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
model controllingOther
control blood pressure by statistical l model with anticipate lowest peri-procedure risk
conventional controllingOther
control blood pressure by conventional strategy
| Study group | Role | What they receive |
|---|---|---|
| model controlling | Experimental | an statistical model for periprocedural blood pressure control Receives: Other: model controlling |
| conventional controlling | Active comparator | an conventional strategy for periprocedural blood pressure control Receives: Other: conventional controlling |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
all cause death
Measured: 30 days
ischemic stroke
Ischemic stroke is defined as an acute episode of neurological events with focal symptoms and signs, with a duration of more than 24h and confirmed by imaging.
Measured: 30 days
cardiovascular events
Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.
Measured: 30 days
Secondary outcomes (4)
transient ischemic attack,TIA
transient ischemic attack, TIA is defined as: Patients with new onset of neurological symptoms and / or signs, duration < 24 hours, MRI diffusion weighted imaging (DWI) did not find new infarcts. If MRI DWI showed new lesion, ischemic stroke was defined.
Measured: 30 days
cerebral hemorrhage
cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage.
Measured: 30 days
hyperperfusion syndrome
Hyperfusion Syndrome is defined as : 30 days after operation, new onset headache, vomiting, mental symptoms, macular edema, focal seizures, neurological dysfunction, or imaging brain edema, visible bleeding, and exception of new ischemic cerebral infarction or other causes.
Measured: 30 days
epilepsy
epilepsy is defined as focal onset, with or without evolution to a bilateral tonic-clonic seizure, confirmed by EEG findings including interictal epileptiform discharges (IEDs), lateralized periodic discharges (LPDs; previously known as periodic lateralized epileptiform discharges [PLEDs]), and generalized periodic discharges (GPDs)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start10 Apr 2017
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral RevascularizationStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University Third Hospital, The 306 Hospital of People's Liberation Army
- Responsible party
- Principal investigator, lingfeng, Xuanwu Hospital, Beijing
- Investigators
- Liqun Jiao, MD, Principal investigator, Department of neurosurgery, Xuanwu hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256513
- Sponsor's protocol ID
- D161100003816002
- Status last verified
- Aug 2017
- First submitted
- 1 Jun 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization for Ischemic Cerebral Vascular Disease
- ClinicalTrials.gov ID
- NCT03256513
- Acronym / sponsor ID
- D161100003816002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,270 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University Third Hospital, The 306 Hospital of People's Liberation Army
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 22 Aug 2017 (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.
Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood flow monitoring and blood pressure, and combining patient demographics and preoperative risk factors to establish an applicable individual blood pressure controlling model. By comparing with routine antihypertensive strategies through prospective randomized controlled trials , to provide the best perioperative blood pressure control standards and strategies for each patient ,thus better ensuring the safety and efficacy of CEA .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| model controlling | Experimental | Other: model controllingan statistical model for periprocedural blood pressure control |
| conventional controlling | Active comparator | Other: conventional controllingan conventional strategy for periprocedural blood pressure control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic patient with carotid artery stenosis>=50% or asymptomatic patient with carotid artery stenosis>=70%, according to DSA or CTA;
- without massive cerebral infarction(infarction area >1/2 territory of middle cerebral artery) confirmed by CT or MRI;
- informed consent acquired.
Key exclusion criteria (13 listed)
- lesion beyond range limit of procedure (higher than C2);
- target vascular complete occlusion or ipsilateral intracranial artery severe stenosis or complete occlusion cannot be revascularized via CEA procedure
- nonatherosclerotic carotid stenosis, such as vasculitis, dissection, congenital vascular malformation;
- history of instable angina pectoris, myocardial infarction or congestive heart failure within 6 months unable to accept systematic anesthesia;
- history of severe injury, surgery or radiotherapy on neck;
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 |
|---|---|---|
| model controllingcontrol blood pressure by statistical l model with anticipate lowest peri-procedure risk | Other | model controlling |
| conventional controllingcontrol blood pressure by conventional strategy | Other | conventional controlling |
Primary outcome
death
Time frame: 30 days
all cause death
ischemic stroke
Time frame: 30 days
Ischemic stroke is defined as an acute episode of neurological events with focal symptoms and signs, with a duration of more than 24h and confirmed by imaging.
cardiovascular events
Time frame: 30 days
Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.
4 secondary outcomes
transient ischemic attack,TIA
Time frame: 30 days
cerebral hemorrhage
Time frame: 30 days
hyperperfusion syndrome
Time frame: 30 days
epilepsy
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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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.
Liqun Jiao, MD principal investigator
Department of neurosurgery, Xuanwu hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cerebral Revascularization and Ischemic Cerebrovascular Disease, run by Xuanwu Hospital, Beijing 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 3 inclusion and 13 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 22 Aug 2017. 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?
Contact Liqun Jiao, MD (86-10-83198899 ext. 8836, jiaoliqun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 30 days). The study lists 3 primary outcomes in all. 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 22 Aug 2017.