NCT05524506

Brief Summary

The purpose is to investigate if different microparticles and markers of hemostasis predict outcome after TIA or ischemic stroke and to study the association between these variables and stroke subtype or etiology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 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

June 1, 2007

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

7.5 years

First QC Date

September 23, 2020

Last Update Submit

August 30, 2022

Conditions

Keywords

Ischemic strokeTIAMicroparticlesMarkers of hemostasisStroke etiology

Outcome Measures

Primary Outcomes (1)

  • Fatal or non-fatal ischemic stroke or myocardial infarction.

    New fatal or non-fatal ischemic stroke after the initial ischemic stroke or TIA leading to recruitment. Outcome events and time of events are extracted from national registries ('Patientregistret', 'Dödsorsaksregistret') and hospital records.

    2007-2014

Secondary Outcomes (2)

  • Recurrent ischemic stroke

    2007-2014

  • All-cause mortality

    2007-2014

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from two hospital stroke units in Stockholm having suffered ischemic stroke or TIA 2007-2009 without known atrial fibrillation and able to handle handheld ECG-recorder.

You may qualify if:

  • acute ischemic stroke or TIA less than 2 weeks before enrollment
  • ability to understand study instructions both verbal and written
  • ability to handle handheld ECG

You may not qualify if:

  • known atrial fibrillation
  • hemorrhagic stroke at time of enrollment
  • limited compliance
  • pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Daderyd Hospital

Stockholm, S-182 88, Sweden

Location

Related Publications (2)

  • Lundstrom A, Mobarrez F, Rooth E, Thalin C, von Arbin M, Henriksson P, Gigante B, Laska AC, Wallen H. Prognostic Value of Circulating Microvesicle Subpopulations in Ischemic Stroke and TIA. Transl Stroke Res. 2020 Aug;11(4):708-719. doi: 10.1007/s12975-019-00777-w. Epub 2020 Jan 25.

    PMID: 31983048BACKGROUND
  • Lundstrom A, Anggardh-Rooth E, Mobarrez F, Thalin C, Gigante B, Laska AC, Wallen H. High Thrombin Generation after Acute Ischemic Stroke or Transient Ischemic Attack Is Associated with a Reduced Risk of Recurrence: An Observational Cohort Study. Thromb Haemost. 2021 May;121(5):584-593. doi: 10.1055/s-0040-1721146. Epub 2020 Dec 12.

    PMID: 33314013BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Platelet-poor plasma (citrated and EDTA)

MeSH Terms

Conditions

Brain IschemiaIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStroke

Study Officials

  • Mårten Rosenqvist, Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 1, 2022

Study Start

June 1, 2007

Primary Completion

December 1, 2014

Study Completion

June 30, 2021

Last Updated

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Not intended at present.

Locations