Thrombus Aspiration in Acute ST-elevation Myocardial Infarction

Acute ST-elevation Myocardial Infarction Clinical Trial

— TASTI  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746822
• Other study ID #: 2015/169
• Status: Completed
• Start date: April 2015
• Est. completion date: January 9, 2019

Study information

• Verified date: October 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 9, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute ST-elevation Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
Norway	Department of Cardiology, Oslo University Hospital, Ullevål	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell composition of the intracoronary thrombus related to symptom length		24 hours