Cerebral Embolic DamageMMP9MPCENCT02109120
MMP-9 Monitoring Particulate Cerebral Embolisation
An observational study of Cerebral Embolic Damage, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
1. In carotid endarterectomy(CEA) surgery, the dynamic changes of plasma MMP9 concentration cross CEA will be identified. 2. And the part of patients suffered particulate cerebral embolic injury, their MMP9 level will increase in the early stage after CEA. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cerebral Embolic Damage
- What is being tested?
- vein blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Nov 2013
- How long will I take part?
- 7 Days
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients under CEA in the PUMCH
Who may be able to join
- -All patients enrolled had at least ≥70% unilateral or bilateral stenosis of Internal -Carotid Artery， or those who had a <70% stenosis but obvious cerebral ischema symptoms had been existed.
Who cannot join
- Refused to cooperate with us
- Nonatheromatous such as takayasu arteritis and fibromuscular dysplasia.
Trial locations and contacts
1 site in 1 country.
China1 site
vascular surgery department of PUMCH
Beijing, Beijing Municipality, 100730
About this study
Official title: Dynamic Changes of MMP9 Concentration Cross Carotid Endarterectomy Monitoring Particulate Cerebral Embolisation
- In carotid endarterectomy(CEA) surgery, the dynamic changes of plasma MMP9 concentration cross CEA will be identified.
- And the part of patients suffered particulate cerebral embolic injury, their MMP9 level will increase in the early stage after CEA.
- Conditions
- Cerebral Embolic Damage
- Being tested
- vein blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vein blood collectionProcedure or surgery
5 ml peripheral vein blood samples were collected from each patient admitted to our study at the following time-points：Pre-operative（morning of surgery），just before declamping，30mins after declamping and post-operative（12h）.
| Study group | Role | What they receive |
|---|---|---|
| carotid endarterectomy (CEA) | CEA patients with vein blood collection Receives: Procedure: vein blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative ischemic stroke
Measured: 7 days after surgery
Secondary outcomes (1)
postoperative elevation of plasma MMP9
Measured: perioperative phage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Embolic DamageStudies 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
- 48 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109120
- Sponsor's protocol ID
- PUMCH-0321
- Acronym
- MMP9MPCE
- Status last verified
- Sep 2013
- First submitted
- 7 Apr 2014
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Molloy KJ, Thompson MM, Schwalbe EC, Bell PR, Naylor AR, Loftus IM. Elevation in plasma MMP-9 following carotid endarterectomy is associated with particulate cerebral embolisation. Eur J Vasc Endovasc Surg. 2004 Apr;27(4):409-13. doi: 10.1016/j.ejvs.2004.02.001.
PubMed 15015192
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes of MMP9 Concentration Cross Carotid Endarterectomy Monitoring Particulate Cerebral Embolisation
- ClinicalTrials.gov ID
- NCT02109120
- Acronym / sponsor ID
- MMP9MPCE / PUMCH-0321
- Conditions
- Cerebral Embolic Damage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Apr 2014 (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.
- In carotid endarterectomy(CEA) surgery, the dynamic changes of plasma MMP9 concentration cross CEA will be identified.
- And the part of patients suffered particulate cerebral embolic injury, their MMP9 level will increase in the early stage after CEA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carotid endarterectomy (CEA) | – | Procedure: vein blood collectionCEA patients with vein blood collection |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients under CEA in the PUMCH
Key inclusion criteria (1 listed)
- -All patients enrolled had at least ≥70% unilateral or bilateral stenosis of Internal -Carotid Artery， or those who had a <70% stenosis but obvious cerebral ischema symptoms had been existed.
Key exclusion criteria (2 listed)
- Refused to cooperate with us
- Nonatheromatous such as takayasu arteritis and fibromuscular dysplasia.
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 |
|---|---|---|
| vein blood collection5 ml peripheral vein blood samples were collected from each patient admitted to our study at the following time-points：Pre-operative（morning of surgery），just before declamping，30mins after declamping and post-operative（12h）. | Procedure or surgery | carotid endarterectomy (CEA) |
Primary outcome
postoperative ischemic stroke
Time frame: 7 days after surgery
1 secondary outcome
postoperative elevation of plasma MMP9
Time frame: perioperative phage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
- Results publication: PubMed 15015192Molloy KJ, Thompson MM, Schwalbe EC, Bell PR, Naylor AR, Loftus IM. Elevation in plasma MMP-9 following carotid endarterectomy is associated with particulate cerebral embolisation. Eur J Vasc Endovasc Surg. 2004 Apr;27(4):409-13. doi: 10.1016/j.ejvs.2004.02.001.
- Related InfoLink provided by the sponsor.
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?
An observational study of Cerebral Embolic Damage, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 9 Apr 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative ischemic stroke (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02109120, which also lists 1 linked publication.
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 9 Apr 2014.