Carotid StenosisNCT01799070
Accuracy of TCD Monitoring in Predicting Cerebral Hyperperfusion Syndrome After Carotid Endarterectomy
An observational study of Carotid Stenosis and Cerebral Hyperperfusion Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Background: Cerebral hyperperfusion syndrome (CHS) is a life threatening complication of carotid endarterectomy (CEA) and the changes of middle cerebral artery velocity are used to predict the occurrence of CHS but the accuracy is limited. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Carotid Stenosis, Cerebral Hyperperfusion Syndrome, Blood Pressure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Dec 2014
- Phase
- Observational
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who with carotid stenosis will accept CEA in PUMCH from March 2013 to September 2014.
Who may be able to join
- Age from 30 to 85 years;
- Had a middle-grade symptomatic carotid stenosis (more than 50%) or a high-grade asymptomatic carotid stenosis (more than 70%);
- Underwent CEA 30 days after the last ischemic cerebrovascular event in the case of symptomatic carotid stenosis;
- Signed the ethical information consent form
- Underwent TCD study intraoperative and immediately after CEA;
- The degree of carotid stenosis will be assessed by CT angiography or cerebral digital subtraction angiography (DSA). (The method document came from the North American Symptomatic Carotid Endarterectomy Trial study.)
Who cannot join
- Emergency CEA within 30 days of stroke onset in the case of symptomatic carotid stenosis;
- No temporal windows to measure the MCAV.
- Restenosis after CEA or CAS
- Stenosis caused by non-atherosclerotic diseases
- Combined severe systematic diseases that markedly decrease the life cycle
- Allergy to medicines of the study such as Aspirin or Statin
- Refuse to sign the ethical information consent form
Trial locations and contacts
1 site in 1 country.
China1 site
vascular surgery department of PUMCH
Beijing, Beijing Municipality, 100730
Bao Liu, MD
Changwei Liu, MD
About this study
Official title: Velocity Systolic Blood Pressure Index in Accurately Predicting Cerebral Hyperperfusion Syndrome After Carotid Endarterectomy
Background: Cerebral hyperperfusion syndrome (CHS) is a life threatening complication of carotid endarterectomy (CEA) and the changes of middle cerebral artery velocity are used to predict the occurrence of CHS but the accuracy is limited. In addition, changes of BP post-operatively comparing with baseline BP should be a predictive factor of CHS.
Objective: The investigators aimed to create a predictive index, velocity systolic blood pressure index (VSI), for improving the predictive power of Transcranial Doppler monitoring regarding CHS.
Read more
Methods: The study design is a diagnostic test, which is an observational analytic clinical study. From March 2013 to September 2014, 200 patients will be recruited. Patients will be classified according to the CHS occurrence. VSI combined the changes of middle cerebral artery velocity and blood pressure crossing CEA and the intra- and post-operative increase ratios of middle cerebral artery velocity were calculated. Their prediction power of CHS will be compared. Sensitivity, specificity, positive predictive value, negative predictive value of them will be calculated. Receiver operating characteristic analysis will be performed.
Expected Outcomes: Comparing with the commonly used intra-operative and post-operative TCD monitoring, VSI may be more useful to select CHS in patients who underwent CEA. As far as the investigators know, analysis or studies combining the BP and velocity changes in the prediction of CHS have never been performed.
Read the detailed description
This study is designed as a standard diagnostic test. It is designed to verify the predictive power of VSI with CHS, and which is an observational analytic clinical study. The investigative parameters of patients will be collected prospectively by the designed case report form. According to the incidence of CHS, the estimated enrollment amount is set as 200. Patients will be recruited by the inclusion and exclusion criteria below. All the patients included will accept the standard CEA surgery treatment in the department of vascular surgery of PUMCH. MCAV and systolic BP data will be recorded cross CEA. Post-operatively the CHS patients will be identified according to the golden standard. The golden standard is the clinical diagnose of CHS (the detailed diagnostic criteria will be stated in the methodology part). The TCD operator is blind to the patients. The predictive power of VSI will be identified by the sensitivity, specificity, positive predictive value, negative predictive value and ROC plot comparing with the golden standard. The study start date is March 2013, the estimated study completion date is December 2014 and the primary completion date is September 2014 (final data collection date for primary outcome measure).
- Keywords
- Prediction, Transcranial Doppler
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral hyperperfusion syndrome
CHS will be diagnosed if (1) the patient developed symptoms that ipsilateral moderate or severe headache, confusion, seizures, intracranial hemorrhage or focal neurological deficits after a symptom-free interval. (2) symptoms not secondary to cerebral ischemia which will be excluded by CT or MRI. (3) MCAV increasing >100% from baseline which identified by TCD. (4) within 7 days after surgery. (5) An independent neurologist made the diagnosis of CHS.
Measured: within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Bao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799070
- Sponsor's protocol ID
- PUMCH-20130113
- Other IDs
- B2009B080
- Status last verified
- Feb 2013
- First submitted
- 24 Feb 2013
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velocity Systolic Blood Pressure Index in Accurately Predicting Cerebral Hyperperfusion Syndrome After Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT01799070
- Acronym / sponsor ID
- PUMCH-20130113
- Keywords
- Prediction, Transcranial Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 26 Feb 2013 (estimated)
- 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.
Background: Cerebral hyperperfusion syndrome (CHS) is a life threatening complication of carotid endarterectomy (CEA) and the changes of middle cerebral artery velocity are used to predict the occurrence of CHS but the accuracy is limited. In addition, changes of BP post-operatively comparing with baseline BP should be a predictive factor of CHS.
Objective: The investigators aimed to create a predictive index, velocity systolic blood pressure index (VSI), for improving the predictive power of Transcranial Doppler monitoring regarding CHS.
Methods: The study design is a diagnostic test, which is an observational analytic clinical study. From March 2013 to September 2014, 200 patients will be recruited. Patients will be classified according to the CHS occurrence. VSI combined the changes of middle cerebral artery velocity and blood pressure crossing CEA and the intra- and post-operative increase ratios of middle cerebral artery velocity were calculated. Their prediction power of CHS will be compared. Sensitivity, specificity, positive predictive value, negative predictive value of them will be calculated. Receiver operating characteristic analysis will be performed.
Expected Outcomes: Comparing with the commonly used intra-operative and post-operative TCD monitoring, VSI may be more useful to select CHS in patients who underwent CEA. As far as the investigators know, analysis or studies combining the BP and velocity changes in the prediction of CHS have never been performed.
Detailed description
This study is designed as a standard diagnostic test. It is designed to verify the predictive power of VSI with CHS, and which is an observational analytic clinical study. The investigative parameters of patients will be collected prospectively by the designed case report form. According to the incidence of CHS, the estimated enrollment amount is set as 200. Patients will be recruited by the inclusion and exclusion criteria below. All the patients included will accept the standard CEA surgery treatment in the department of vascular surgery of PUMCH. MCAV and systolic BP data will be recorded cross CEA. Post-operatively the CHS patients will be identified according to the golden standard. The golden standard is the clinical diagnose of CHS (the detailed diagnostic criteria will be stated in the methodology part). The TCD operator is blind to the patients. The predictive power of VSI will be identified by the sensitivity, specificity, positive predictive value, negative predictive value and ROC plot comparing with the golden standard. The study start date is March 2013, the estimated study completion date is December 2014 and the primary completion date is September 2014 (final data collection date for primary outcome measure).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHS | – | – |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who with carotid stenosis will accept CEA in PUMCH from March 2013 to September 2014.
Key inclusion criteria (6 listed)
- Age from 30 to 85 years;
- Had a middle-grade symptomatic carotid stenosis (more than 50%) or a high-grade asymptomatic carotid stenosis (more than 70%);
- Underwent CEA 30 days after the last ischemic cerebrovascular event in the case of symptomatic carotid stenosis;
- Signed the ethical information consent form
- Underwent TCD study intraoperative and immediately after CEA;
Key exclusion criteria (7 listed)
- Emergency CEA within 30 days of stroke onset in the case of symptomatic carotid stenosis;
- No temporal windows to measure the MCAV.
- Restenosis after CEA or CAS
- Stenosis caused by non-atherosclerotic diseases
- Combined severe systematic diseases that markedly decrease the life cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cerebral hyperperfusion syndrome
Time frame: within 7 days after surgery
CHS will be diagnosed if (1) the patient developed symptoms that ipsilateral moderate or severe headache, confusion, seizures, intracranial hemorrhage or focal neurological deficits after a symptom-free interval. (2) symptoms not secondary to cerebral ischemia which will be excluded by CT or MRI. (3) MCAV increasing >100% from baseline which identified by TCD. (4) within 7 days after surgery. (5) An independent neurologist made the diagnosis of CHS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis and Cerebral Hyperperfusion Syndrome, run by Peking Union Medical College Hospital 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 7 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 26 Feb 2013. 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 Bao Liu, MD (+86-10-88068230, liubao72@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral hyperperfusion syndrome (time frame: within 7 days after surgery). 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 26 Feb 2013.