NCT02746822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2019

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

3.8 years

First QC Date

April 8, 2016

Last Update Submit

October 6, 2020

Conditions

Keywords

acute myocardial infarction,thrombus aspiration

Outcome Measures

Primary Outcomes (1)

  • Cell composition of the intracoronary thrombus related to symptom length

    24 hours

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute St-elevation myocardial infarction

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Oslo University Hospital, Ullevål

Oslo, 0407, Norway

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

thrombus material and blood

Study Officials

  • Ingebjørg Seljeflot, Professor

    Kirkeveien 166, 0407 Oslo, Norway

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 21, 2016

Study Start

April 1, 2015

Primary Completion

January 9, 2019

Study Completion

January 9, 2019

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations