Precision Medicine in Stroke

NCT05815836 | Completed

• 1 other identifier: LMU_ISD_2023_PROMISE
• Study Type: observational
• Target: 787
• Locations: 0 countries
• Sites: N/A

Brief 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 the circulating proteome and metabolome as well as other entities.

Conditions

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

Keywords

Biomarker; Stroke; Diagnosis; Pathophysiology

Outcome Measures

Primary Outcomes (2)

• 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 \[raw values, referenced to HC, or referenced to SM\]

  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 \[raw values, referenced to HC, or referenced to SM\]

  7 days or day of discharge if earlier (on average 5 days)

Secondary Outcomes (8)

• Acute brain injury as assessed by neuroimaging

  day 1

• Subacute brain injury as assessed by neuroimaging

  day 3 to day 10

• Neck and cerebral vessel morphology

  day 1 to day 10

• Heart morphology and function as assessed by echocardiography and ECG

  day 1 to day 10

• Stroke etiology

  7 days or day of discharge if earlier (on average 5 days)

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with stroke-like symptoms as well as healthy subjects.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, platelet-poor plasma, DNA

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 18, 2023
• Study Start: October 1, 2013
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: IPD and additional supporting information will become available starting 6 months after publication.
• Access Criteria: IPD and additional supporting information will be shared with academic researchers with a reasonable request to the corresponding author of the respective publication.