Ischemia Reperfusion InjuryNCT03397732
Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury
An observational study of Ischemia Reperfusion Injury, run by University of Pecs.
Trial summary
The MMP-9-TIMP-1 system has been implicated in many physiological and pathophysiological conditions including vascular surgery related ischemic-reperfusion injury. Our key aims were to establish the early perioperative time courses of the aforementioned system in aorto-bifemoral bypass and aorta stentgraft… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia Reperfusion Injury
- What is being tested?
- aorto-bifemoral bypass and aorta stentgraft
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jun 2013
- 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 atherosclerotic and/or aorta aneurysma generaly associated with hypertension and diabetes
Who may be able to join
- Scheduled for elective procedure (aorto-bifemoral bypass or aorta stentgraft implantation) by vascular surgeons.
- Over age 18
- agree to participate
Who cannot join
- under age 18
- refuse to participate
- diagnosed malignant disease
- chronic steroid usage
- being on cytostatic therapy
About this study
The MMP-9-TIMP-1 system has been implicated in many physiological and pathophysiological conditions including vascular surgery related ischemic-reperfusion injury. Our key aims were to establish the early perioperative time courses of the aforementioned system in aorto-bifemoral bypass and aorta stentgraft implantation procedures and to find correlation between the MMP-9-TIMP-1 system and the cross-clamp time. Patients were prospectively enrolled after Ethical Committee approval. Blood samples were taken at four different time points (T1-4): T1: right before surgery, T2: 60 min after the cross-clamp release, T3: first postoperative morning, 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. MMP- 9 and TIMP-1 were determined by the quantitative sandwich enzyme-linked immunosorbent assay (ELISA) techniques according to the manufacturer instructions (R\&D Systems Inc., Minneapolis, Minnesota, USA). In comparison with standard curves, the concentrations of MMP-9 and TIMP-1 in plasma were determined spectrophotometrically (Multiskan Ascent microplate photometer, Type: 354, Thermo Electron Corporation, Waltham, Massachusetts, USA) by reading the absorbance at 450 nm. Plasma concentrations of MMP-9 and TIMP-1 were expressed as ng/ml.
- Conditions
- Ischemia Reperfusion Injury
- Being tested
- aorto-bifemoral bypass and aorta stentgraft
- Keywords
- Matrix metalloproteinase, Tissue inhibitor of matrix metalloproteinase, Vascular surgery, Aorta stent implantation, Aorto-bifemoral bypass surgery
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aorto-bifemoral bypass and aorta stentgraftProcedure or surgery
Surgical implantation of aorto-bifemoral bypass or aorta stentgraft under general and/or regional anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Aorto-bifemoral bypass | Patients scheduled for elective aorto-bifemoral bypass surgery by vascular surgeons and consented to participate in the study. Receives: Procedure: aorto-bifemoral bypass and aorta stentgraft | |
| Aorta stentgraft | Patients scheduled for elective aorta stentgraft implantation by vascular surgeons and consented to participate in the study. Receives: Procedure: aorto-bifemoral bypass and aorta stentgraft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative time course of the MMP-9-TIMP-1 system
To establish the early perioperative time course of MMP-9-TIMP-1 system in aorto-bifemoral bypass and aorta stentgraft implantation.
Measured: 3 days
Secondary outcomes (1)
MMP-9-TIMP-1 system and ischemia-reperfusion injury
To explore relationship between MMP-9-TIMP-1 system and vascular surgery related ischemia-reperfusion injury
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Jan 2012
- Primary completion1 Jun 2013
- Study completion1 Jun 2013
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 Ischemia Reperfusion InjuryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 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
- Diána Mühl, MD, PhD, Study chair, University of Pécs, Dept. of Anaesthesia and Intensive Care Pécs, Baranya county, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397732
- Sponsor's protocol ID
- 4330
- Status last verified
- Jan 2018
- First submitted
- 6 Jan 2018
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagy B, Szelig L, Rendeki S, Loibl C, Rezman B, Lantos J, Bogar L, Csontos C. Dynamic changes of matrix metalloproteinase 9 and tissue inhibitor of metalloproteinase 1 after burn injury. J Crit Care. 2015 Feb;30(1):162-6. doi: 10.1016/j.jcrc.2014.07.008. Epub 2014 Jul 11.
PubMed 25155253Muhl D, Nagy B, Woth G, Falusi B, Bogar L, Weber G, Lantos J. Dynamic changes of matrix metalloproteinases and their tissue inhibitors in severe sepsis. J Crit Care. 2011 Dec;26(6):550-5. doi: 10.1016/j.jcrc.2011.02.011. Epub 2011 May 6.
PubMed 21530151
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury
- ClinicalTrials.gov ID
- NCT03397732
- Acronym / sponsor ID
- 4330
- Conditions
- Ischemia Reperfusion Injury
- Keywords
- Matrix metalloproteinase, Tissue inhibitor of matrix metalloproteinase, Vascular surgery, Aorta stent implantation, Aorto-bifemoral bypass surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 1 Jun 2013 (actual)
- First posted
- 12 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 MMP-9-TIMP-1 system has been implicated in many physiological and pathophysiological conditions including vascular surgery related ischemic-reperfusion injury. Our key aims were to establish the early perioperative time courses of the aforementioned system in aorto-bifemoral bypass and aorta stentgraft implantation procedures and to find correlation between the MMP-9-TIMP-1 system and the cross-clamp time. Patients were prospectively enrolled after Ethical Committee approval. Blood samples were taken at four different time points (T1-4): T1: right before surgery, T2: 60 min after the cross-clamp release, T3: first postoperative morning, 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. MMP- 9 and TIMP-1 were determined by the quantitative sandwich enzyme-linked immunosorbent assay (ELISA) techniques according to the manufacturer instructions (R\&D Systems Inc., Minneapolis, Minnesota, USA). In comparison with standard curves, the concentrations of MMP-9 and TIMP-1 in plasma were determined spectrophotometrically (Multiskan Ascent microplate photometer, Type: 354, Thermo Electron Corporation, Waltham, Massachusetts, USA) by reading the absorbance at 450 nm. Plasma concentrations of MMP-9 and TIMP-1 were expressed as ng/ml.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aorto-bifemoral bypass | – | Procedure: aorto-bifemoral bypass and aorta stentgraftPatients scheduled for elective aorto-bifemoral bypass surgery by vascular surgeons and consented to participate in the study. |
| Aorta stentgraft | – | Procedure: aorto-bifemoral bypass and aorta stentgraftPatients scheduled for elective aorta stentgraft implantation by vascular surgeons and consented to participate in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed atherosclerotic and/or aorta aneurysma generaly associated with hypertension and diabetes
Key inclusion criteria (3 listed)
- Scheduled for elective procedure (aorto-bifemoral bypass or aorta stentgraft implantation) by vascular surgeons.
- Over age 18
- agree to participate
Key exclusion criteria (5 listed)
- under age 18
- refuse to participate
- diagnosed malignant disease
- chronic steroid usage
- being on cytostatic therapy
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 |
|---|---|---|
| aorto-bifemoral bypass and aorta stentgraftSurgical implantation of aorto-bifemoral bypass or aorta stentgraft under general and/or regional anaesthesia. | Procedure or surgery | Aorta stentgraft, Aorto-bifemoral bypass |
Primary outcome
Perioperative time course of the MMP-9-TIMP-1 system
Time frame: 3 days
To establish the early perioperative time course of MMP-9-TIMP-1 system in aorto-bifemoral bypass and aorta stentgraft implantation.
1 secondary outcome
MMP-9-TIMP-1 system and ischemia-reperfusion injury
Time frame: 3 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 12 Jan 2018.
- Results publication: PubMed 25155253Nagy B, Szelig L, Rendeki S, Loibl C, Rezman B, Lantos J, Bogar L, Csontos C. Dynamic changes of matrix metalloproteinase 9 and tissue inhibitor of metalloproteinase 1 after burn injury. J Crit Care. 2015 Feb;30(1):162-6. doi: 10.1016/j.jcrc.2014.07.008. Epub 2014 Jul 11.
- Results publication: PubMed 21530151Muhl D, Nagy B, Woth G, Falusi B, Bogar L, Weber G, Lantos J. Dynamic changes of matrix metalloproteinases and their tissue inhibitors in severe sepsis. J Crit Care. 2011 Dec;26(6):550-5. doi: 10.1016/j.jcrc.2011.02.011. Epub 2011 May 6.
- 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.
Diána Mühl, MD, PhD study chair
University of Pécs, Dept. of Anaesthesia and Intensive Care Pécs, Baranya county, Hungary
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia Reperfusion Injury, run by University of Pecs.
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 5 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 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Perioperative time course of the MMP-9-TIMP-1 system (time frame: 3 days). 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 NCT03397732, 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 12 Jan 2018.