Plaque Imaging in Routine Care to Detect Intraplaque Hemorrhage

NCT ID: NCT06749106

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2029-12-31

Brief Summary

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.

Detailed Description

Stroke is one of the leading causes of death and the leading cause of permanent disability. Identifying the underlying etiology is crucial as secondary stroke prevention strategies vary depending on the cause of the stroke. However, in approximately 30% of patients, no clear etiology can be identified (cryptogenic stroke), preventing these patients from receiving targeted treatment.

Recent findings indicate that features of plaque vulnerability are associated with acute ischemic stroke which also applies to patients with cryptogenic stroke who have a carotid artery stenosis of less than 50%. Features of plaque vulnerability can be assessed by high-resolution carotid magnetic resonance imaging (MRI) which enables noninvasive detailed characterization of atherosclerotic carotid artery plaques. Hence, plaque imaging allows to detect vulnerable plaques and to further stratify stroke etiology. In addition, plaque imaging may identify patients with vulnerable plaques who are at risk for a recurrent ischemic stroke or TIA.

However, integrating multisequence high-resolution, contrast-enhanced MRI into the standard diagnostic workflow of acute stroke would prove difficult, thus calling for simpler imaging protocols. Unlike other features of plaque vulnerability, intraplaque hemorrhage (IPH) can be reliably detected by standard coils and conventional native black-blood fat-saturated T1-weighted sequences. Given the frequency of IPH, previous study results, and additional literature evidencing the importance of IPH as a marker for plaque vulnerability and risk of stroke recurrence, a single black-blood fat-saturated T1-weighted sequence was added to the MR imaging protocol for the diagnostic work-up of stroke patients at LMU hospital.

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. 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.

In principle, the detection of IPH points towards the presence of an increased plaque vulnerability. However, it is unknown whether IPH can be reliably detected on routine clinical scans and whether information on the presence or absence of IPH should influence clinical decision making. Depending on the results, the outcome of this study might benefit future generations of patients by improving the diagnostic assignment to a specific stroke etiology and risk assessment with respect to recurrent vascular events.

Conditions

Acute Ischemic Stroke

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

acute ischemic stroke

Patients with acute ischemic stroke, who received non-contrast carotid MRI for routine diagnostic work-up

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with acute ischemic stroke
• Availability of non-contrast carotid MRI scans obtained through routine diagnostic work-up

Exclusion Criteria

• 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
• Life expectancy < 1 year
• Inability to provide written informed consent

This eligibility criteria apply for the prospective part of the PARADE study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LMU Klinikum - Department of Neuroradiology

UNKNOWN

Sponsor Role: collaborator

LMU Klinikum - Department of Neurology

UNKNOWN

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Martin Dichgans

Prof. Dr. med. Martin Dichgans

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Kopczak, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Stroke and Dementia Research

Locations

Institute for Stroke and Dementia Research

Munich, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Martin Dichgans, Prof.

Role: CONTACT

isd@med.uni-muenchen.de

+49 89 4400 46019

Anna Kopczak, MD

Role: CONTACT

Other Identifiers

PARADE

Identifier Type: -

Identifier Source: org_study_id