Carotid StenosisNCT03410576
Perioperative Time Course of MMP-9 and Its Inhibitor During Carotid Artery Stenting and Carotid Endarterectomy
An observational study of Carotid Stenosis and Ischemia Reperfusion Injury, run by University of Pecs at 1 site in Hungary.
Trial summary
The aim was the comparison of the perioperative time courses of matrix metalloproteinase-9 (MMP-9) and its inhibitor (TIMP-1) during elective carotid artery stenting (CAS). The investigators used a matched, historical carotid endarteriectomy group as controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis, Ischemia Reperfusion Injury
- What is being tested?
- Carotid artery stenting and Carotid endarterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteHungary
- Study dates
- 1 Oct 2013to 30 Nov 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed carotid artery stenosis
Who may be able to join
- elective carotid artery surgery
Who cannot join
- Malignant diseases, inflammatory and systemic autoimmune disorders, psychiatric disorders and previous debilitating stroke
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs
Pécs, Baranya, H-7624
About this study
Official title: Comparison of the Perioperative Time Course of Matrix Metalloproteinase-9 (MMP-9) and Its Inhibitor (TIMP-1) During Carotid Artery Stenting (CAS) and Carotid Endarterectomy (CEA)
The aim was the comparison of the perioperative time courses of matrix metalloproteinase-9 (MMP-9) and its inhibitor (TIMP-1) during elective carotid artery stenting (CAS). The investigators used a matched, historical carotid endarteriectomy group as controls. Blood samples at four time points: T1: preoperative; T2: 60 minutes after stent insertion; T3: first postoperative morning; and T4: third postoperative morning. Plasma was isolated from heparin anticoagulated blood samples by low speed centrifugation at 4 °C, and stored at -80 °C until analyzed in a single batch at the end of the study. Plasma concentrations of MMP-9 and TIMP-1 were expressed as ng/ml.
- Conditions
- Carotid Stenosis, Ischemia Reperfusion Injury
- Being tested
- Carotid artery stenting, Carotid endarterectomy
- Keywords
- Matrix metalloproteinase, Carotid artery stenting, Carotid endarterectomy
- Medical subject headings
- Carotid Stenosis, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid artery stentingProcedure or surgery
Patient undergo elective carotid artery stenting. In this patient group blood sampling was performed at three time points: T1, at the time of the insertion of the arterial line; T2, 60 min after stent insertion; and T3: the first postoperative morning.
Carotid endarterectomyProcedure or surgery
Patient undergo elective carotid endarterectomy. Group samples were collected at the following four time points: T1, at the time of the insertion of the arterial line; T2, 60 min after cross-clamp release; T3, the first postoperative morning; and T4, the third postoperative morning. A matched subgroup of patients from the previously obtained data served as a historical control.
| Study group | Role | What they receive |
|---|---|---|
| Carotid artery stenting | Patients undergo carotid artery stenting. Receives: Procedure: Carotid artery stenting | |
| Carotid endarterectomy | Patients receive elective carotid endarterectomy. Receives: Procedure: Carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma MMP-9 concentrations
Plasma is isolated from heparin-anticoagulated blood samples by low speed centrifugation at 4 °C. MMP-9 levels were measured with quantitative sandwich enzyme-linked immunosorbent assay.
Measured: 4 days
Plasma TIMP-1 concentrations
Plasma is isolated from heparin-anticoagulated blood samples by low speed centrifugation at 4 °C. TIMP-1 levels were measured with quantitative sandwich enzyme-linked immunosorbent assay.
Measured: 4 days
Secondary outcomes (1)
MMP-9/TIMP-1 ratio
MMP-9/TIMP-1 is calculated from the measured plasma MMP-9 and TIMP-1 concentrations
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Oct 2013
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gábor László Woth, University of Pecs
- Investigators
- Gábor Woth, MD, PhD, Principal investigator, Department of Anaesthesiology and Intensive Therapy, Medical School, University of PécsBálint Nagy, MD, PhD, Principal investigator, Department of Anaesthesiology and Intensive Therapy, Medical School, University of PécsDiana Mühl, MD, PhD, Study director, Department of Anaesthesiology and Intensive Therapy, Medical School, University of PécsJános Lantos, PhD, Principal investigator, Department of Surgical Research and Techniques, Medical School, University of Pécs,Ferenc Kövér, MD, Principal investigator, Department of Neurosurgery, Medical School, University of Pécs,Lajos Bogár, MD, DsC, Principal investigator, Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410576
- Sponsor's protocol ID
- 5016
- Status last verified
- Jan 2018
- First submitted
- 6 Jan 2018
- Last updated
- 25 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagy B, Woth G, Merei A, Nagy L, Lantos J, Menyhei G, Bogar L, Muhl D. Perioperative time course of matrix metalloproteinase-9 (MMP-9), its tissue inhibitor TIMP-1 & S100B protein in carotid surgery. Indian J Med Res. 2016 Feb;143(2):220-6. doi: 10.4103/0971-5916.180212.
PubMed 27121520Merei A, Nagy B, Woth G, Lantos J, Kover F, Bogar L, Muhl D. Comparison of the perioperative time courses of matrix metalloproteinase-9 (MMP-9) and its inhibitor (TIMP-1) during carotid artery stenting (CAS) and carotid endarterectomy (CEA). BMC Neurol. 2018 Aug 29;18(1):128. doi: 10.1186/s12883-018-1133-1.
PubMed 30157791
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Perioperative Time Course of Matrix Metalloproteinase-9 (MMP-9) and Its Inhibitor (TIMP-1) During Carotid Artery Stenting (CAS) and Carotid Endarterectomy (CEA)
- ClinicalTrials.gov ID
- NCT03410576
- Acronym / sponsor ID
- 5016
- Conditions
- Carotid Stenosis, Ischemia Reperfusion Injury
- Keywords
- Matrix metalloproteinase, Carotid artery stenting, Carotid endarterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 25 Jan 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.
The aim was the comparison of the perioperative time courses of matrix metalloproteinase-9 (MMP-9) and its inhibitor (TIMP-1) during elective carotid artery stenting (CAS). The investigators used a matched, historical carotid endarteriectomy group as controls. Blood samples at four time points: T1: preoperative; T2: 60 minutes after stent insertion; T3: first postoperative morning; and T4: third postoperative morning. Plasma was isolated from heparin anticoagulated blood samples by low speed centrifugation at 4 °C, and stored at -80 °C until analyzed in a single batch at the end of the study. Plasma concentrations of MMP-9 and TIMP-1 were expressed as ng/ml.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid artery stenting | – | Procedure: Carotid artery stentingPatients undergo carotid artery stenting. |
| Carotid endarterectomy | – | Procedure: Carotid endarterectomyPatients receive elective carotid endarterectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed carotid artery stenosis
Key inclusion criteria (1 listed)
- elective carotid artery surgery
Key exclusion criteria (1 listed)
- Malignant diseases, inflammatory and systemic autoimmune disorders, psychiatric disorders and previous debilitating stroke
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 |
|---|---|---|
| Carotid artery stentingPatient undergo elective carotid artery stenting. In this patient group blood sampling was performed at three time points: T1, at the time of the insertion of the arterial line; T2, 60 min after stent insertion; and T3: the first postoperative morning. | Procedure or surgery | Carotid artery stenting |
| Carotid endarterectomyPatient undergo elective carotid endarterectomy. Group samples were collected at the following four time points: T1, at the time of the insertion of the arterial line; T2, 60 min after cross-clamp release; T3, the first postoperative morning; and T4, the third postoperative morning. A matched subgroup of patients from the previously obtained data served as a historical control. | Procedure or surgery | Carotid endarterectomy |
Primary outcome
Plasma MMP-9 concentrations
Time frame: 4 days
Plasma is isolated from heparin-anticoagulated blood samples by low speed centrifugation at 4 °C. MMP-9 levels were measured with quantitative sandwich enzyme-linked immunosorbent assay.
Plasma TIMP-1 concentrations
Time frame: 4 days
Plasma is isolated from heparin-anticoagulated blood samples by low speed centrifugation at 4 °C. TIMP-1 levels were measured with quantitative sandwich enzyme-linked immunosorbent assay.
1 secondary outcome
MMP-9/TIMP-1 ratio
Time frame: 4 days
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 25 Jan 2018.
- Background: PubMed 27121520Nagy B, Woth G, Merei A, Nagy L, Lantos J, Menyhei G, Bogar L, Muhl D. Perioperative time course of matrix metalloproteinase-9 (MMP-9), its tissue inhibitor TIMP-1 & S100B protein in carotid surgery. Indian J Med Res. 2016 Feb;143(2):220-6. doi: 10.4103/0971-5916.180212.
- Derived from this study: PubMed 30157791Merei A, Nagy B, Woth G, Lantos J, Kover F, Bogar L, Muhl D. Comparison of the perioperative time courses of matrix metalloproteinase-9 (MMP-9) and its inhibitor (TIMP-1) during carotid artery stenting (CAS) and carotid endarterectomy (CEA). BMC Neurol. 2018 Aug 29;18(1):128. doi: 10.1186/s12883-018-1133-1.
- Individual participant dataSharing planned: No
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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.
Gábor Woth, MD, PhD principal investigator
Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs
Bálint Nagy, MD, PhD principal investigator
Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs
Diana Mühl, MD, PhD study director
Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs
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 Ischemia Reperfusion Injury, run by University of Pecs at 1 site in Hungary.
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 1 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 25 Jan 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 Hungary. 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?
Plasma MMP-9 concentrations (time frame: 4 days). The study lists 2 primary outcomes in all. 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 NCT03410576, which also lists 2 linked publications.
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 25 Jan 2018.