Acute Ischemic StrokePARADENCT06749106
Plaque Imaging in Routine Care to Detect Intraplaque Hemorrhage
An observational study of Acute Ischemic Stroke, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jan 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with acute ischemic stroke
- Availability of non-contrast carotid MRI scans obtained through routine diagnostic work-up
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Kopczak, MD contact
Germany1 site, 1 recruiting
- Recruiting
Institute for Stroke and Dementia Research
Munich, 81377
About this study
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.
Read the 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
- Keywords
- plaque imaging, plaque vulnerability, cryptogenic stroke, routine care, stroke etiology, recurrent stroke, intraplaque hemorrhage, IPH, acute ischemic stroke, AIS
- Medical subject headings
- Ischemic Stroke, Stroke
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 |
|---|---|---|
| acute ischemic stroke | Patients with acute ischemic stroke, who received non-contrast carotid MRI for routine diagnostic work-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraplaque hemorrhage (IPH)
presence of IPH as detected on routine non-contrast MRI
Measured: baseline
Secondary outcomes (5)
recurrent ischemic stroke or TIA
recurrent ischemic stroke or transient ischemic attack (TIA)
Measured: 3 months, 12 months
Plaque-RADS
scoring plaque vulnerability according to the Plaque-RADS (Reporting and Data System) classification (score [1-4] with higher scores meaning higher plaque vulnerability) with all data available from clinical routine
Measured: baseline
Barthel Scale
activities of daily living, assessed using the Barthel Scale (score [0-100] with lower scores meaning lower independence in activities of daily living)
Measured: baseline, 3 months, 12 months
modified Rankin Scale (mRS)
modified Rankin Scale (mRS) as a functional global outcome scale measuring the level of disability after stroke (score [0-6] with higher scores meaning a worse outcome)
Measured: baseline, 3 months, 12 months
National Institutes of Health Stroke Scale (NIHSS)
stroke severity, assessed using the National Institutes of Health Stroke Scale (NIHSS) (score [0-42] with higher scores meaning higher stroke severity)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start16 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- LMU Klinikum
- Responsible party
- Principal investigator, Martin Dichgans, Ludwig-Maximilians - University of Munich
- Investigators
- Anna Kopczak, MD, Principal investigator, Institute for Stroke and Dementia Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749106
- Sponsor's protocol ID
- PARADE
- Acronym
- PARADE
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: depending on the research proposal and the variables required
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Imaging in Routine Care to Detect Intraplaque Hemorrhage
- ClinicalTrials.gov ID
- NCT06749106
- Acronym / sponsor ID
- PARADE / PARADE
- Conditions
- Acute Ischemic Stroke
- Keywords
- plaque imaging, plaque vulnerability, cryptogenic stroke, routine care, stroke etiology, recurrent stroke, intraplaque hemorrhage, IPH
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- LMU Klinikum
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Dec 2024 (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 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute ischemic stroke | – | –Patients with acute ischemic stroke, who received non-contrast carotid MRI for routine diagnostic work-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with acute ischemic stroke
- Availability of non-contrast carotid MRI scans obtained through routine diagnostic work-up
Key exclusion criteria (7 listed)
- 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
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
intraplaque hemorrhage (IPH)
Time frame: baseline
presence of IPH as detected on routine non-contrast MRI
5 secondary outcomes
recurrent ischemic stroke or TIA
Time frame: 3 months, 12 months
Plaque-RADS
Time frame: baseline
Barthel Scale
Time frame: baseline, 3 months, 12 months
modified Rankin Scale (mRS)
Time frame: baseline, 3 months, 12 months
National Institutes of Health Stroke Scale (NIHSS)
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Undecided. depending on the research proposal and the variables required
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Anna Kopczak, MD contact
Anna Kopczak, MD principal investigator
Institute for Stroke and Dementia Research
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 Acute Ischemic Stroke, run by Ludwig-Maximilians - University of Munich 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Dichgans, Prof. (+49 89 4400 46019, isd@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraplaque hemorrhage (IPH) (time frame: baseline). 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 24 Jan 2025.