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Clinical Trials/NCT02746822
NCT02746822
Completed
Not Applicable

Thrombus Aspiration in Acute ST-elevation Myocardial Infarction

Oslo University Hospital1 site in 1 country36 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute ST-elevation Myocardial Infarction
Sponsor
Oslo University Hospital
Enrollment
36
Locations
1
Primary Endpoint
Cell composition of the intracoronary thrombus related to symptom length
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Thirty patients with acute ST-elevation myocardial infarction treated with primary PCI and aspiration of thrombus material from the infarct related coronary artery will be included. Both cellular and non cellular content of the thrombus will be examined with morphological and immunohistochemical methods and related to time from onset of symptoms to PCI, as well as to the degree of myocardial necrosis. Furthermore, mRNA expression of selected signal molecules will be performed. In addition, peripheral venous blood samples will be drawn and analyzed for signalling molecules and corresponding mRNA expression in circulating leukocytes.

Detailed Description

Observational, cross-sectional study on 30 patients with STEMI treated with thrombectomy and PCI with stent implantation. Composition and characteristics of the coronary thrombi with respect to cell types, genetic expression and presence of specific markers of inflammation, platelet activity, endothelial activation, coagulation and fibrinolysis will be investigated in relation to the levels of these markers in the general circulation, and specifically related to the time axis from symptom to PCI, as well as to the degree of myocardial necrosis. Intracoronary thrombus will be retrieved by standard aspiration catheter, washed with saline and stored on formalin as advised by the Department of pathology, OUS Ullevål. A specific protocol for morphological and immunohistochemical methods is prepared and has been shown suitable in a pilot study on 5 patients. Assessment of coronary TIMI flow and peripheral blush grade after thrombus aspiration and PCI will be done. At the same time, peripheral venous blood will be drawn, processed and stored at -80˚C for later analyses. Demographic variables will be recorded.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
January 9, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Svein Solheim

MD, PhD

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • Both gender
  • age 18-75 years
  • typical symptoms of acute myocardial infarction
  • ST-elevation or presumed new left bundle branch block in the ECG
  • treated with aspiration of thrombus and primary PCI in the infarct related coronary artery

Exclusion Criteria

  • Signs of infection
  • pulmonary embolism
  • chronic obstructive pulmonary disease
  • arrhythmias, abnormal renal and/or liver function
  • autoimmune disease
  • malignant disease

Outcomes

Primary Outcomes

Cell composition of the intracoronary thrombus related to symptom length

Time Frame: 24 hours

Study Sites (1)

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