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Completed

NCT Number: NCT02746822

Thrombus Aspiration in Acute ST-elevation Myocardial Infarction

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.

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Key information

Conditions

Acute ST-elevation Myocardial Infarction

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Oslo University Hospital, Ullevål

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cell composition of the intracoronary thrombus related to symptom length

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: TASTI

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2016
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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