Plaque Imaging in Routine Care to Detect Intraplaque Hemorrhage

NCT06749106 | Recruiting

• 1 other identifier: PARADE
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

plaque imaging; plaque vulnerability; cryptogenic stroke; routine care; stroke etiology; recurrent stroke; intraplaque hemorrhage; IPH; acute ischemic stroke; AIS

Outcome Measures

Primary Outcomes (1)

• intraplaque hemorrhage (IPH)

  presence of IPH as detected on routine non-contrast MRI

  baseline

Secondary Outcomes (5)

• recurrent ischemic stroke or TIA

  3 months, 12 months

• Plaque-RADS

  baseline

• Barthel Scale

  baseline, 3 months, 12 months

• modified Rankin Scale (mRS)

  baseline, 3 months, 12 months

• National Institutes of Health Stroke Scale (NIHSS)

  baseline

Study Arms (1)

acute ischemic stroke

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• LMU Klinikum - Department of Neuroradiology: collaborator
• LMU Klinikum - Department of Neurology: collaborator

Study Sites (1)

Institute for Stroke and Dementia Research

Munich, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anna Kopczak, MD

  Institute for Stroke and Dementia Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Dichgans, Prof.

CONTACT

+49 89 4400 46019; isd@med.uni-muenchen.de

Anna Kopczak, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Martin Dichgans

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

DE (1)