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

Carotid Stenosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410576
• Other study ID #: 5016
• Status: Completed
• Phase: N/A
• First received: January 6, 2018
• Last updated: January 18, 2018
• Start date: October 1, 2013
• Est. completion date: November 30, 2015

Study information

• Verified date: January 2018
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 30, 2015
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

elective carotid artery surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Carotid Stenosis
• Ischemia
• Ischemia Reperfusion Injury
• Reperfusion Injury

Intervention

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
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.

Locations

Country	Name	City	State
Hungary	Department of Anaesthesiology and Intensive Therapy, Medical School, University of Pécs	Pécs	Baranya

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

Nagy B, Woth G, Mérei Á, Nagy L, Lantos J, Menyhei G, Bogár L, Mühl 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	MMP-9/TIMP-1 ratio	MMP-9/TIMP-1 is calculated from the measured plasma MMP-9 and TIMP-1 concentrations	4 days