MedDataX Logo

Precision Medicine in Stroke

NCT ID: NCT05815836

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

787 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Brain Ischemia Nervous System Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Biomarker Stroke Diagnosis Pathophysiology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Steffen Tiedt

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LMU_ISD_2023_PROMISE

Identifier Type: -

Identifier Source: org_study_id