Health TrialsbyHealthPanel

Plaque Imaging in Routine Care to Detect Intraplaque Hemorrhage

ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLudwig-Maximilians - University of Munich

About this trial

The aim of this study is to investigate the association between intraplaque hemorrhage (IPH) detected by non-contrast magnetic resonance imaging (MRI) of the carotid artery in routine clinical practice and ipsilateral acute ischemic events. The investigators' overarching aim is to determine whether this sequence aids the diagnostic work-up of stroke patients.

For this purpose, the investigators set up a prospective single-center longitudinal observational study with one year follow-up. In addition, this study will analyze retrospectively obtained data collected through clinical routine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with acute ischemic stroke

Availability of non-contrast carotid MRI scans obtained through routine diagnostic work-up

Disqualifiers

Infarct in the posterior circulation or bilateral ischemic infarcts

Time between symptom onset and non-contrast carotid MRI > 10 days

Prior stenting of a carotid artery or carotid endarterectomy

Age < 18 years

Trial population

Patients with acute ischemic stroke, who received non-contrast carotid MRI for routine diagnostic work-up, will be asked whether they are willing to participate in a prospective, longitudinal study with telephone follow-up to assess recurrent ischemic stroke or TIA. Patients who are unable to provide informed consent for themselves, children and adolescents will not be recruited. Detailed eligibility criteria for the prospective longitudinal study are provided above. In addition, this study will analyse retrospectively obtained data collected through clinical routine: These analyses will be done on all patients who received non-contrast carotid MRI for routine diagnostic work-up over the last years. This approach allows to estimate the prevalence of IPH in an unselected patient population.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: acute ischemic stroke

Trial outcomes

Primary outcomes

1

intraplaque hemorrhage (IPH)

presence of IPH as detected on routine non-contrast MRI

Time frame
baseline

Secondary outcomes

1

recurrent ischemic stroke or TIA

recurrent ischemic stroke or transient ischemic attack (TIA)

Time frame
3 months, 12 months
2

Plaque-RADS

scoring plaque vulnerability according to the Plaque-RADS (Reporting and Data System) classification (score \[1-4\] with higher scores meaning higher plaque vulnerability) with all data available from clinical routine

Time frame
baseline
3

Barthel Scale

activities of daily living, assessed using the Barthel Scale (score \[0-100\] with lower scores meaning lower independence in activities of daily living)

Time frame
baseline, 3 months, 12 months
4

modified Rankin Scale (mRS)

modified Rankin Scale (mRS) as a functional global outcome scale measuring the level of disability after stroke (score \[0-6\] with higher scores meaning a worse outcome)

Time frame
baseline, 3 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ludwig-Maximilians - University of Munich

Lead sponsor

LMU Klinikum

Collaborator

Source ClinicalTrials.gov
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