Acute ST-elevation Myocardial InfarctionTASTINCT02746822
Thrombus Aspiration in Acute ST-elevation Myocardial Infarction
An observational study of Acute ST-elevation Myocardial Infarction, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute ST-elevation Myocardial Infarction
- How many people
- 36 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2015to 9 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute St-elevation myocardial infarction
Who may be able to join
- 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
Who cannot join
- Signs of infection
- pulmonary embolism
- chronic obstructive pulmonary disease
- arrhythmias, abnormal renal and/or liver function
- autoimmune disease
- malignant disease
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Cardiology, Oslo University Hospital, Ullevål
Oslo, 0407
About this study
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.
Read the 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.
- Conditions
- Acute ST-elevation Myocardial Infarction
- Keywords
- acute myocardial infarction,, thrombus aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell composition of the intracoronary thrombus related to symptom length
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2015
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svein Solheim, Oslo University Hospital
- Investigators
- Ingebjørg Seljeflot, Professor, Study chair, Kirkeveien 166, 0407 Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746822
- Sponsor's protocol ID
- 2015/169
- Acronym
- TASTI
- Status last verified
- Oct 2020
- First submitted
- 8 Apr 2016
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35488283Nordeng 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.
PubMed 35102064Nordeng 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.
PubMed 34135690
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombus Aspiration in Acute ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02746822
- Acronym / sponsor ID
- TASTI / 2015/169
- Conditions
- Acute ST-elevation Myocardial Infarction
- Keywords
- acute myocardial infarction,, thrombus aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute St-elevation myocardial infarction
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Signs of infection
- pulmonary embolism
- chronic obstructive pulmonary disease
- arrhythmias, abnormal renal and/or liver function
- autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | – |
Primary outcome
Cell composition of the intracoronary thrombus related to symptom length
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 35488283Nordeng 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.
- Derived from this study: PubMed 35102064Nordeng 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.
- Derived from this study: PubMed 34135690Nordeng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingebjørg Seljeflot, Professor study chair
Kirkeveien 166, 0407 Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute ST-elevation Myocardial Infarction, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell composition of the intracoronary thrombus related to symptom length (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02746822, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.