Perioperative Time Course of MMP-9 and Its Inhibitor During Carotid Artery Stenting and Carotid Endarterectomy

January 18, 2018 updated by: Gábor László Woth, University of Pecs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, H-7624
        • Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Diagnosed carotid artery stenosis

Description

Inclusion Criteria:

elective carotid artery surgery

Exclusion Criteria:

Malignant diseases, inflammatory and systemic autoimmune disorders, psychiatric disorders and previous debilitating stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Carotid artery stenting
Patients undergo carotid artery stenting.
Procedure: Carotid artery stenting
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 endarterectomy
Patients receive elective carotid endarterectomy.
Procedure: Carotid endarterectomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 days
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.
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMP-9/TIMP-1 ratio
Time Frame: 4 days
MMP-9/TIMP-1 is calculated from the measured plasma MMP-9 and TIMP-1 concentrations
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Investigators

  • Principal Investigator: Gábor Woth, MD, PhD, Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs
  • Principal Investigator: Bálint Nagy, MD, PhD, Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs
  • Study Director: Diana Mühl, MD, PhD, Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs
  • Principal Investigator: János Lantos, PhD, Department of Surgical Research and Techniques, Medical School, University of Pécs,
  • Principal Investigator: Ferenc Kövér, MD, Department of Neurosurgery, Medical School, University of Pécs,
  • Principal Investigator: Lajos Bogár, MD, DsC, Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2013

Primary Completion (ACTUAL)

November 30, 2015

Study Completion (ACTUAL)

November 30, 2015

Study Registration Dates

First Submitted

January 6, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (ACTUAL)

January 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carotid Stenosis

Clinical Trials on Carotid artery stenting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe