StrokePROMISENCT05815836
Precision Medicine in Stroke
An observational study of Stroke and Cerebrovascular Disorders, run by Ludwig-Maximilians - University of Munich.
Trial summary
PROMISE aims at identifying novel diagnostic and prognostic circulating biomarkers for patients with acute stroke and at informing on crucial yet undetected pathophysiological mechanisms driving outcome after stroke by enriching all phenotypic information available from clinical routine with in-depth quantification of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Brain Diseases
- How many people
- 787 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 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 admitted with stroke-like symptoms as well as healthy subjects.
Who may be able to join
- Patients with acute ischemic stroke:
- Age 18 years or older
- Diagnosis of an acute ischemic stroke defined by an acute focal neurological deficit in combination with a diffusion-weighted imaging-positive lesion on magnetic resonance imaging or a new lesion on a delayed CT scan.
- Time from last seen well to admission and first blood sampling < 24 hours
- Blood samples collected upon admission (day 1), the next morning (day 2), day 3, and day 7 (or day of discharge if earlier)
- Informed consent in accord with ethical approval
Show all 21Show fewer
- Patients with acute intracerebral hemorrhage:
- Age 18 years or older
- Diagnosis of an acute intracerebral hemorrhage defined by an acute focal neurological deficit in combination with imaging-based evidence of intracerebral hemorrhage.
- Time from last seen well to admission and first blood sampling < 24 hours
- Blood samples collected upon admission (day 1)
- Informed consent in accord with ethical approval
- Patients with stroke mimics:
- Age 18 years or older
- Diagnosis of a stroke-mimicking disease defined by an acute focal neurological deficit in combination with a lack of infarction on neuroimaging.
- Time from last seen well to admission and first blood sampling < 24 hours
- Blood samples collected upon admission (day 1), the next morning (day 2), day 3, and day 7
- Informed consent in accord with ethical approval
- Healthy subjects:
- Age 18 years or older
- Informed consent in accord with ethical approval
Who cannot join
- Patients with acute ischemic stroke:
- Lack of follow-up CT or MRI imaging
- Major surgery within the last four weeks
- In-house stroke
- Myocardial infarction, ischemic stroke, transient ischemic attacks, traumatic brain injury, cerebral venous sinus thrombosis, any intracranial hemorrhage, thrombosis, or pulmonary embolism within the last four weeks
- Chronic inflammatory bowel disease or percutaneous endoscopic gastrostomy
Show all 19Show fewer
- Patients with acute intracerebral hemorrhage:
- Major surgery within the last four weeks
- In-house stroke
- Myocardial infarction, ischemic stroke, transient ischemic attacks, traumatic brain injury, cerebral venous sinus thrombosis, any intracranial hemorrhage, thrombosis, or pulmonary embolism within the last four weeks
- Chronic inflammatory bowel disease or percutaneous endoscopic gastrostomy
- Patients with stroke mimics:
- Major surgery within the last four weeks
- Myocardial infarction, ischemic stroke, transient ischemic attacks, traumatic brain injury, cerebral venous sinus thrombosis, any intracranial hemorrhage, thrombosis, or pulmonary embolism within the last four weeks
- Chronic inflammatory bowel disease or percutaneous endoscopic gastrostomy
- Healthy subjects:
- Major surgery within the last four weeks
- Myocardial infarction, ischemic stroke, transient ischemic attacks, traumatic brain injury, cerebral venous sinus thrombosis, any intracranial hemorrhage, thrombosis, or pulmonary embolism within the last four weeks
- Chronic inflammatory bowel disease or percutaneous endoscopic gastrostomy
About this study
PROMISE aims at identifying novel diagnostic and prognostic circulating biomarkers for patients with acute stroke and at informing on crucial yet undetected pathophysiological mechanisms driving outcome after stroke by enriching all phenotypic information available from clinical routine with in-depth quantification of the circulating proteome and metabolome as well as other entities.
Read the detailed description
The heterogeneity of ischemic stroke (IS) poses a challenge for assigning patients to optimal treatment strategies and is a major reason for the large number of failed clinical trials. Current diagnostic algorithms are insufficient to explain clinical outcomes arguing for crucial yet undetected pathophysiological mechanisms. Diagnostic tests further leave stroke etiology undetermined in 40 % of IS patients thus impeding the allocation of these patients to optimal secondary prevention regimens. Heterogeneity is also seen at the level of neuronal injury, which greatly varies between IS patients, but can neither be assessed in the pre-hospital setting nor serially in the acute phase to monitor stroke progression and to develop individual trajectories of neuronal loss over time. The circulating proteome and metabolome capture pathophysiological events from multiple organs including local and systemic events (e.g. stress) related to acute stroke and might thus inform on neuronal injury and the mechanisms causing stroke. The circulating proteome and metabolome may further inform on i) the systemic effects of stroke, which contribute significantly to stroke outcome but are under-researched, and ii) how concepts from preclinical stroke research such as reperfusion injury translate to human stroke. The investigators hypothesize that the combination of detailed clinical phenotyping with advanced profiling technologies (genomics, proteomics, and metabolomics) will enable the identification of key molecular signatures of IS that inform on pathophysiological mechanisms and might also be utilized as diagnostic instruments.
- Conditions
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Brain Ischemia, Nervous System Diseases
- Keywords
- Biomarker, Stroke, Diagnosis, Pathophysiology
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Brain Ischemia, Nervous System Diseases, Disease
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 | 504 patients admitted to a specialized stroke service because of an acute ischemic stroke. The circulating proteome and metabolome as well as specific molecular targets of interest (i.e. NfL) will be assessed upon admission (day 1), the next morning (day 2), day 3, day 7 (or day of discharge if earlier), and day 90. Routinely collected clinical data including from neuroimaging will be collected throughout hospitalization. Clinical follow-up will be performed at 3 months. | |
| Acute Intracerebral hemorrhage | 130 patients admitted to a specialized stroke service because of an acute intracerebral hemorrhage. The circulating proteome and metabolome as well as specific molecular targets of interest (i.e. NfL) will be assessed upon admission (day 1). Routinely collected clinical data including from neuroimaging will be collected throughout hospitalization. | |
| Stroke Mimics | 51 patients admitted to the emergency department because of acute stroke-like symptoms caused by epileptic seizures, migraine attacks, or other stroke-mimicking diseases. The circulating proteome and metabolome as well as specific molecular targets of interest (i.e. NfL) will be assessed upon admission (day 1), the next morning (day 2), day 3, day 7, and day 90. Routinely collected clinical data including from neuroimaging will be collected throughout hospitalization. | |
| Healthy subjects | 102 subjects without acute neurological symptoms. The circulating proteome and metabolome as well as specific molecular targets of interest (i.e. NfL) will be assessed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of clinical outcome as defined by the modified Rankin Scale (mRS) score
The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death. We will assess associations of clinical outcome with:
- Global, class, pathway, and individual metabolite levels upon admission (day 1), day 2, day 3, day7, and day 90 [raw values, referenced to HC, or referenced to SM]
- Global, pathway, and individual protein levels upon admission (day 1), day 2, day 3, day7, and day 90 [raw values, referenced to HC, or referenced to SM]
Measured: 3 months
Prediction of clinical outcome as defined by the modified Rankin Scale (mRS) score
The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death. We will assess associations of clinical outcome with:
- Global, class, pathway, and individual metabolite levels upon admission (day 1), day 2, day 3, and day 7 [raw values, referenced to HC, or referenced to SM]
- Global, pathway, and individual protein levels upon admission (day 1), day 2, day 3, and day 7 [raw values, referenced to HC, or referenced to SM]
Measured: 7 days or day of discharge if earlier (on average 5 days)
Secondary outcomes (8)
Acute brain injury as assessed by neuroimaging
The extent of acute brain injury (in ml) will be assessed on admission NCCT and CT perfusion scans.
Measured: day 1
Subacute brain injury as assessed by neuroimaging
The extent of subacute brain injury will be manually segmented on images from delayed routine CT or MRI scans.
Measured: day 3 to day 10
Neck and cerebral vessel morphology
We will assess the number of different plaque types on routine CT/MRI angiography scans.
Measured: day 1 to day 10
Heart morphology and function as assessed by echocardiography and ECG
We will assess the likelihood of cardiac embolism by a score that integrates PTFV1, left ventricular strain and left atrial area.
Measured: day 1 to day 10
Stroke etiology
Stroke etiology will be assessed using the TOAST classification systems.
Measured: 7 days or day of discharge if earlier (on average 5 days)
Sensitivity and specificity to separet diagnostic groups
Groups (Ischemic stroke, hemorrhagic stroke, stroke mimics, healthy subjects) will be compared.
Measured: day 1 to day 10
Systemic sequelae of stroke
Systemic sequelae will be assessed by clinical laboratory tests.
Measured: day 1 to day 10
Treatment efficacy of mechanical thrombectomy
Treatment efficacy will be assessed by comparing mRS scores between treated and non-treated groups.
Measured: day 1 to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startOct 2013
- Primary completionNov 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 787 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffen Tiedt, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815836
- Sponsor's protocol ID
- LMU_ISD_2023_PROMISE
- Acronym
- PROMISE
- Status last verified
- Dec 2023
- First submitted
- 9 Mar 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data, including data dictionaries, that underlie results in a publication, will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine in Stroke
- ClinicalTrials.gov ID
- NCT05815836
- Acronym / sponsor ID
- PROMISE / LMU_ISD_2023_PROMISE
- Conditions
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Brain Ischemia, Nervous System Diseases
- Keywords
- Biomarker, Stroke, Diagnosis, Pathophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 787 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Nov 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 18 Apr 2023 (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.
PROMISE aims at identifying novel diagnostic and prognostic circulating biomarkers for patients with acute stroke and at informing on crucial yet undetected pathophysiological mechanisms driving outcome after stroke by enriching all phenotypic information available from clinical routine with in-depth quantification of the circulating proteome and metabolome as well as other entities.
Detailed description
The heterogeneity of ischemic stroke (IS) poses a challenge for assigning patients to optimal treatment strategies and is a major reason for the large number of failed clinical trials. Current diagnostic algorithms are insufficient to explain clinical outcomes arguing for crucial yet undetected pathophysiological mechanisms. Diagnostic tests further leave stroke etiology undetermined in 40 % of IS patients thus impeding the allocation of these patients to optimal secondary prevention regimens. Heterogeneity is also seen at the level of neuronal injury, which greatly varies between IS patients, but can neither be assessed in the pre-hospital setting nor serially in the acute phase to monitor stroke progression and to develop individual trajectories of neuronal loss over time. The circulating proteome and metabolome capture pathophysiological events from multiple organs including local and systemic events (e.g. stress) related to acute stroke and might thus inform on neuronal injury and the mechanisms causing stroke. The circulating proteome and metabolome may further inform on i) the systemic effects of stroke, which contribute significantly to stroke outcome but are under-researched, and ii) how concepts from preclinical stroke research such as reperfusion injury translate to human stroke. The investigators hypothesize that the combination of detailed clinical phenotyping with advanced profiling technologies (genomics, proteomics, and metabolomics) will enable the identification of key molecular signatures of IS that inform on pathophysiological mechanisms and might also be utilized as diagnostic instruments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute Ischemic Stroke | – | –504 patients admitted to a specialized stroke service because of an acute ischemic stroke. The circulating proteome and metabolome as well as specific molecular targets of interest (i.e. NfL) will be assessed upon admission (day 1), the next morning (day 2), day 3, day 7 (or day of discharge if earlier), and day 90. Routinely collected clinical data including from neuroimaging will be collected throughout hospitalization. Clinical follow-up will be performed at 3 months. |
| Acute Intracerebral hemorrhage | – | –130 patients admitted to a specialized stroke service because of an acute intracerebral hemorrhage. The circulating proteome and metabolome as well as specific molecular targets of interest (i.e. NfL) will be assessed upon admission (day 1). Routinely collected clinical data including from neuroimaging will be collected throughout hospitalization. |
| Stroke Mimics | – | –51 patients admitted to the emergency department because of acute stroke-like symptoms caused by epileptic seizures, migraine attacks, or other stroke-mimicking diseases. The circulating proteome and metabolome as well as specific molecular targets of interest (i.e. NfL) will be assessed upon admission (day 1), the next morning (day 2), day 3, day 7, and day 90. Routinely collected clinical data including from neuroimaging will be collected throughout hospitalization. |
| Healthy subjects | – | –102 subjects without acute neurological symptoms. The circulating proteome and metabolome as well as specific molecular targets of interest (i.e. NfL) will be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with stroke-like symptoms as well as healthy subjects.
Key inclusion criteria (21 listed)
- Patients with acute ischemic stroke:
- Age 18 years or older
- Diagnosis of an acute ischemic stroke defined by an acute focal neurological deficit in combination with a diffusion-weighted imaging-positive lesion on magnetic resonance imaging or a new lesion on a delayed CT scan.
- Time from last seen well to admission and first blood sampling < 24 hours
- Blood samples collected upon admission (day 1), the next morning (day 2), day 3, and day 7 (or day of discharge if earlier)
Key exclusion criteria (19 listed)
- Patients with acute ischemic stroke:
- Lack of follow-up CT or MRI imaging
- Major surgery within the last four weeks
- In-house stroke
- Myocardial infarction, ischemic stroke, transient ischemic attacks, traumatic brain injury, cerebral venous sinus thrombosis, any intracranial hemorrhage, thrombosis, or pulmonary embolism within the last four weeks
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
Prediction of clinical outcome as defined by the modified Rankin Scale (mRS) score
Time frame: 3 months
The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death. We will assess associations of clinical outcome with: * Global, class, pathway, and individual metabolite levels upon admission (day 1), day 2, day 3, day7, and day 90 [raw values, referenced to HC, or referenced to SM] * Global, pathway, and individual protein levels upon admission (day 1), day 2, day 3, day7, and day 90 [raw values, referenced to HC, or referenced to SM]
Prediction of clinical outcome as defined by the modified Rankin Scale (mRS) score
Time frame: 7 days or day of discharge if earlier (on average 5 days)
The modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death. We will assess associations of clinical outcome with: * Global, class, pathway, and individual metabolite levels upon admission (day 1), day 2, day 3, and day 7 [raw values, referenced to HC, or referenced to SM] * Global, pathway, and individual protein levels upon admission (day 1), day 2, day 3, and day 7 [raw values, referenced to HC, or referenced to SM]
8 secondary outcomes
Acute brain injury as assessed by neuroimaging
Time frame: day 1
Subacute brain injury as assessed by neuroimaging
Time frame: day 3 to day 10
Neck and cerebral vessel morphology
Time frame: day 1 to day 10
Heart morphology and function as assessed by echocardiography and ECG
Time frame: day 1 to day 10
Stroke etiology
Time frame: 7 days or day of discharge if earlier (on average 5 days)
Sensitivity and specificity to separet diagnostic groups
Time frame: day 1 to day 10
Systemic sequelae of stroke
Time frame: day 1 to day 10
Treatment efficacy of mechanical thrombectomy
Time frame: day 1 to day 90
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 11 Dec 2023.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data, including data dictionaries, that underlie results in a publication, will be made available.
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cerebrovascular Disorders, run by Ludwig-Maximilians - University of Munich.
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 21 inclusion and 19 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Prediction of clinical outcome as defined by the modified Rankin Scale (mRS) score (time frame: 3 months). The study lists 2 primary outcomes in all. 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 11 Dec 2023.