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

NCT ID: NCT03555643

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 96 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2021-10-31

Brief Summary

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.

Conditions

TIA; Stroke; Ischemia; Diagnoses Disease

Study Design

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

Study Groups

transient ischemic attack (TIA)

Patients with transient ischemic attack

No interventions assigned to this group

transient neurological attack (TNA)

Patients with transient neurological attack

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsmedizin Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Alex Förster

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alex Förster, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mannheim, Dept. of Neuroradiology

Locations

Universitätsmedizin Mannheim

Mannheim, , Germany

Countries

Germany

Other Identifiers

2016-591N-MA

Identifier Type: -

Identifier Source: org_study_id