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NCT05815836Completed

Precision Medicine in Stroke

Source: ClinicalTrials.gov · Last updated 11 Dec 2023

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
787 (actual)
First submitted
9 Mar 2023
Start date
Oct 2013
Primary completion date
Nov 2023
Lead sponsor
Ludwig-Maximilians - University of Munich
Diseases
Stroke
NCT number
NCT05815836

What you commit to

  • Study type: Observational
  • Participants enrolled: 787
  • From Oct 2013 to the primary completion date, Nov 2023
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Major surgery within the last four weeks
  • Major surgery within the last four weeks
  • Major surgery within the last four weeks
  • Major surgery within the last four weeks

Other illness

  • Patients with acute ischemic stroke:
  • 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:
  • 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:
  • 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
  • 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

Other

  • Lack of follow-up CT or MRI imaging
  • Healthy subjects:

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.