Thrombus Aspiration in Acute ST-elevation Myocardial Infa... | NCT02746822

Studies
Thrombus Aspiration in Acute ST-elevation Myocardial Infarction

NCT02746822

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Oct 8, 2020Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Acute ST-elevation Myocardial Infarction

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Jan 9, 2019Actual

Completion Date

Jan 9, 2019Actual

First Submitted Date

Apr 8, 2016

First Submission Date that Met QC Criteria

Apr 18, 2016

First Posted Date

Apr 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2020

Last Update Posted Date

Oct 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

36Actual

Name	Type	Description	Arm Group Labels	Other Names
	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cell composition of the intracoronary thrombus related to symptom length		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with acute St-elevation myocardial infarction

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ingebjørg Seljeflot, Professor	Kirkeveien 166, 0407 Oslo, Norway	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Oslo University Hospital, Ullevål		Oslo		0407	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35488283	Derived	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.
35102064	Derived	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.