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

NCT03410576 | Completed

• 1 other identifier: 5016
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Matrix metalloproteinase; Carotid artery stenting; Carotid endarterectomy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 days

Secondary Outcomes (1)

• MMP-9/TIMP-1 ratio

  4 days

Study Arms (2)

Carotid artery stenting

Patients undergo carotid artery stenting.

Procedure: Carotid artery stenting

Carotid endarterectomy

Patients receive elective carotid endarterectomy.

Procedure: Carotid endarterectomy

Interventions

Carotid artery stenting PROCEDURE

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 artery stenting

Carotid endarterectomy PROCEDURE

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.

Carotid endarterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diagnosed carotid artery stenosis

You may qualify if:

• elective carotid artery surgery

You may not qualify if:

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

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs

Pécs, Baranya, H-7624, Hungary

Location

Related Publications (2)

• 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.

  PMID: 27121520 BACKGROUND

• Merei 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.

  PMID: 30157791 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Carotid Stenosis; Reperfusion Injury

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Diana Mühl, MD, PhD

  Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: January 25, 2018
• Study Start: October 1, 2013
• Primary Completion: November 30, 2015
• Study Completion: November 30, 2015
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)