Acute Ischemic StrokePROMoSDNCT05580198
Prognostic Markers of Post-Stroke Depression (PROMoSD)
An observational study of Acute Ischemic Stroke, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Single-center prospective observational study investigating the association of brainstem raphe hypoechogenicity detected by transcranial sonography and post-stroke depression three months after an acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Transcranial sonography.
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to Mar 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who present with an acute ischemic stroke to the emergency department with the onset of symptoms within the past 14 days.
Who may be able to join
- Acute ischemic stroke with the onset of symptoms within the past 14 days
- Diagnosis of AIS is confirmed by brain imaging, either computer tomography or magnetic resonance imaging
Who cannot join
- Insufficient transtemporal bone window for transcranial sonography examination
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
St. Josef-Hospital Bochum
Bochum, North Rhine-Westphalia, 44791
Daniel Richter, Dr., 00492345090, daniel.richter-c34@rub.de
About this study
Official title: Prognostic Markers of Post-Stroke Depression: A Single-center Prospective Observational Study
Single-center prospective observational study investigating the association of brainstem raphe hypoechogenicity detected by transcranial sonography and post-stroke depression three months after an acute ischemic stroke.
Read the detailed description
Post-stroke depression (PSD) is an important complication after a stroke. Despite significant limitations between studies of PSD risk factors, stroke severity or post-stroke disability, prior depressive episodes, and female sex are arguably the most well-known risk factors for developing PSD, although the predictive value of these factors is limited.
A hypoechogenic brainstem raphe (BR) detected by transcranial sonography (TCS) is associated with depressive symptoms in distinct diseases but is also common with approximately 25% of the non-depressed population in Europe. The primary aim of this study is to investigate the association between BR hypoechogenicity and PSD occurrence in a prospective observational study design.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Transcranial sonography.
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial sonography.Diagnostic test
Transcranial sonography examination to determine the brainstem raphe echogenicity.
| Study group | Role | What they receive |
|---|---|---|
| BRH+ | Acute ischemic stroke patients with brainstem raphe hypoechogenicity. Receives: Diagnostic Test: Transcranial sonography. | |
| BRH- | Acute ischemic stroke patients without brainstem raphe hypoechogenicity. Receives: Diagnostic Test: Transcranial sonography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-stroke depression
PSD diagnosis was defined according to the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V criteria) or by any new medication for anti-depressive indication during follow-up
Measured: 3 months
Secondary outcomes (1)
Severity of depressive symptoms
Measured by the Hamilton Depression Rating Scale (HRSD, minimum score: 0, maximum score: 52), with higher scores indicating greater severity of depressive symptoms.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Jan 2021
- Primary completionNov 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christos Krogias, Ruhr University of Bochum
- Investigators
- Christos Krogias, Prof., Principal investigator, St. Josef-Hospital Bochum, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580198
- Sponsor's protocol ID
- 20-6862
- Acronym
- PROMoSD
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Richter D, Ebert A, Mazul-Wach L, Ruland Q, Charles-James J, Gold R, Tsivgoulis G, Juckel G, Krogias C. Prognostic markers of post-stroke depression (PROMoSD): study protocol of a prospective single-center observational study on raphe hypoechogenicity as a predictor of post-stroke depression. Neurol Res Pract. 2022 Dec 9;4(1):59. doi: 10.1186/s42466-022-00225-5.
PubMed 36494874
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Markers of Post-Stroke Depression: A Single-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05580198
- Acronym / sponsor ID
- PROMoSD / 20-6862
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 14 Oct 2022 (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.
Single-center prospective observational study investigating the association of brainstem raphe hypoechogenicity detected by transcranial sonography and post-stroke depression three months after an acute ischemic stroke.
Detailed description
Post-stroke depression (PSD) is an important complication after a stroke. Despite significant limitations between studies of PSD risk factors, stroke severity or post-stroke disability, prior depressive episodes, and female sex are arguably the most well-known risk factors for developing PSD, although the predictive value of these factors is limited.
A hypoechogenic brainstem raphe (BR) detected by transcranial sonography (TCS) is associated with depressive symptoms in distinct diseases but is also common with approximately 25% of the non-depressed population in Europe. The primary aim of this study is to investigate the association between BR hypoechogenicity and PSD occurrence in a prospective observational study design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRH+ | – | Diagnostic Test: Transcranial sonography.Acute ischemic stroke patients with brainstem raphe hypoechogenicity. |
| BRH- | – | Diagnostic Test: Transcranial sonography.Acute ischemic stroke patients without brainstem raphe hypoechogenicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present with an acute ischemic stroke to the emergency department with the onset of symptoms within the past 14 days.
Key inclusion criteria (2 listed)
- Acute ischemic stroke with the onset of symptoms within the past 14 days
- Diagnosis of AIS is confirmed by brain imaging, either computer tomography or magnetic resonance imaging
Key exclusion criteria (1 listed)
- Insufficient transtemporal bone window for transcranial sonography examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial sonography.Transcranial sonography examination to determine the brainstem raphe echogenicity. | Diagnostic test | BRH+, BRH- |
Primary outcome
Post-stroke depression
Time frame: 3 months
PSD diagnosis was defined according to the fifth version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V criteria) or by any new medication for anti-depressive indication during follow-up
1 secondary outcome
Severity of depressive symptoms
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Derived from this study: PubMed 36494874Richter D, Ebert A, Mazul-Wach L, Ruland Q, Charles-James J, Gold R, Tsivgoulis G, Juckel G, Krogias C. Prognostic markers of post-stroke depression (PROMoSD): study protocol of a prospective single-center observational study on raphe hypoechogenicity as a predictor of post-stroke depression. Neurol Res Pract. 2022 Dec 9;4(1):59. doi: 10.1186/s42466-022-00225-5.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Christos Krogias, Prof. principal investigator
St. Josef-Hospital Bochum, Ruhr-University Bochum
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 Ruhr University of Bochum 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 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Richter, Dr, (00492345090, daniel.richter-c34@rub.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-stroke depression (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05580198, which also lists 1 linked publication.
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 17 Oct 2022.