TIANCT03555643
Evaluation of the HARM for the Detection of a Cerebral Ischemia in TIA/TNA Patients
An observational study of TIA and Stroke, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- TIA, Stroke, Ischemia, Diagnoses Disease
- Keywords
- TIA, Stroke, Ischemia, MRI, FLAIR, hyperintense acute reperfusion marker
- Medical subject headings
- Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| transient ischemic attack (TIA) | Patients with transient ischemic attack | |
| transient neurological attack (TNA) | Patients with transient neurological attack |
What is being measured
The primary outcome is the main question the study is designed to answer.
hyperintense acute reperfusion marker (HARM)
Detection of the hyperintense acute reperfusion marker (HARM) on postcontrast FLAIR images.
Measured: within 24 hours after onset of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Nov 2017
- Primary completion31 Oct 2020
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Förster, Universitätsmedizin Mannheim
- Investigators
- Alex Förster, MD, Principal investigator, Universitätsmedizin Mannheim, Dept. of Neuroradiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555643
- Sponsor's protocol ID
- 2016-591N-MA
- Status last verified
- Feb 2024
- First submitted
- 1 Jun 2018
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03555643
- Acronym / sponsor ID
- 2016-591N-MA
- Conditions
- TIA, Stroke, Ischemia, Diagnoses Disease
- Keywords
- TIA, Stroke, Ischemia, MRI, FLAIR, hyperintense acute reperfusion marker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transient ischemic attack (TIA) | – | –Patients with transient ischemic attack |
| transient neurological attack (TNA) | – | –Patients with transient neurological attack |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hyperintense acute reperfusion marker (HARM)
Time frame: within 24 hours after onset of symptoms
Detection of the hyperintense acute reperfusion marker (HARM) on postcontrast FLAIR images.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Förster, MD principal investigator
Universitätsmedizin Mannheim, Dept. of Neuroradiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TIA and Stroke, run by Universitätsmedizin Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hyperintense acute reperfusion marker (HARM) (time frame: within 24 hours after onset of symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.