Evaluation of the HARM for the Detection of a Cerebral Ischemia in TIA/TNA Patients

Evaluation of the Hyperintense Acute Reperfusion Marker for the Detection of a Cerebral Ischemia in the Anterior and Posterior Circulation in Patients With Transient Ischemic/Neurological Attack

The research project investigates the incidence of the hyperintense acute reperfusion marker (HARM) in patients with transient ischemic attack (TIA) or transient neurological attack (TNA). Initially, HARM was described after acute ischemic stroke and is caused by a blood-brain barrier disorder after recanalization of an acute vessel occlusion and consecutive reperfusion. These result in a contrast agent extravasation into the subarachnoid space, which can be easily detected on fluid attenuated inversion recovery (FLAIR) images.

TIA is defined as a transient focal neurological deficit with a probably cerebrovascular cause. In contrast, TNA is defined as a transient non-focal neurological deficit with multiple causes, including cerebrovascular. The clinical diagnosis of TIA is often flawed and the delineation of TIA and TNA can be difficult. MRI is the most important diagnostic method for the detection or exclusion of cerebral ischemia in patients with TIA/TNA in daily clinical practice. However, on diffusion-weighted imaging (DWI) approximately two-thirds of TIA cases and only one-fifth of TNA cases demonstrate acute cerebral ischemia. Supplementary perfusion-weighted imaging (PWI) scans can only slightly increase this percentage. The well-known HARM could prove to be complementary to DWI and PWI and close or at least reduce the existing gap. In the case of TNA in particular, this could be of clinical relevance in order to avoid mistreatment or even dismissal without further clarification after supposedly inconspicuous imaging.

Therefore, the aim of this study is to record the incidence of HARM in a statistically significant number of cases of patients with TIA and TNA and to investigate relationships with symptom duration and anatomical localization. In addition, the dynamics of contrast enhancement in the subarachnoid space in TIA and TNA cases with HARM will be analyzed in detail.

Study Overview

• Status: Completed
• Conditions: Ischemia; Stroke; Diagnoses Disease; TIA

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • Universitätsmedizin Mannheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients (≥ 50 years) with transient focal or non-focal neurological symptoms who are eligible for an MRI examination within 24 hours after onset of symptoms and able to give informed consent.

Description

Inclusion Criteria:

• transient focal neurological symptoms (aphasia, facial paresis, hemiparesis, hemihypaesthesia, double vision, hemianopia, hemiataxia, etc.)
• transient non-focal neurological symptoms (confusion, dizziness, memory deficits, gait insecurity, bilateral weakness, etc.)
• MRI examination possible within 24 hours of symptoms
• able to give informed consent

Exclusion Criteria:

• persistent symptoms
• symptoms lasting more than > 24 h
• clinical suspicion of other cause of symptoms (seizures, intoxication, hypoglycemia, psychogenic)
• contraindications for MRI (pacemaker, metallic splinter, cochlear implants, etc.)
• unable to give consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
transient ischemic attack (TIA); Patients with transient ischemic attack
transient neurological attack (TNA); Patients with transient neurological attack

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hyperintense acute reperfusion marker (HARM)	Detection of the hyperintense acute reperfusion marker (HARM) on postcontrast FLAIR images.	within 24 hours after onset of symptoms

Collaborators and Investigators

• Sponsor: Universitätsmedizin Mannheim
• Investigators: Principal Investigator: Alex Förster, MD, Universitätsmedizin Mannheim, Dept. of Neuroradiology

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Stroke; Ischemia; TIA; FLAIR; hyperintense acute reperfusion marker
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Stroke; Brain Infarction; Brain Ischemia; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 2016-591N-MA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No