Thrombus Aspiration in Acute ST-elevation Myocardial Infarction

NCT ID: NCT02746822

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-01-09

Brief Summary

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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

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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.

Conditions

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Acute ST-elevation Myocardial Infarction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Svein Solheim

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingebjørg Seljeflot, Professor

Role: STUDY_CHAIR

Kirkeveien 166, 0407 Oslo, Norway

Locations

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Department of Cardiology, Oslo University Hospital, Ullevål

Oslo, , Norway

Site Status

Countries

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Norway

References

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Nordeng J, Solheim S, Akra S, Schandiz H, Hoffmann P, Roald B, Bendz B, Arnesen H, Helseth R, Seljeflot I. Gene expression of fibrinolytic markers in coronary thrombi. Thromb J. 2022 Apr 29;20(1):23. doi: 10.1186/s12959-022-00383-1.

Reference Type DERIVED
PMID: 35488283 (View on PubMed)

Nordeng J, Schandiz H, Solheim S, Akra S, Hoffman P, Roald B, Bendz B, Arnesen H, Helseth R, Seljeflot I. TIMP-1 expression in coronary thrombi associate with myocardial injury in ST-elevation myocardial infarction patients. Coron Artery Dis. 2022 Sep 1;33(6):446-455. doi: 10.1097/MCA.0000000000001128. Epub 2022 Jan 31.

Reference Type DERIVED
PMID: 35102064 (View on PubMed)

Nordeng J, Schandiz H, Solheim S, Akra S, Hoffman P, Roald B, Bendz B, Arnesen H, Helseth R, Seljeflot I. The Inflammasome Signaling Pathway Is Actively Regulated and Related to Myocardial Damage in Coronary Thrombi from Patients with STEMI. Mediators Inflamm. 2021 May 27;2021:5525917. doi: 10.1155/2021/5525917. eCollection 2021.

Reference Type DERIVED
PMID: 34135690 (View on PubMed)

Other Identifiers

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2015/169

Identifier Type: -

Identifier Source: org_study_id

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