NCT07041372

Brief Summary

The goal of this clinical trial is to learn if the application of fluorodeoxyglucose positron emission tomography can predict prognosis of stroke patients. The main questions it aims to answer are:

  • Does FDG PET can predict future vascular events such as stroke recurrence, myocardial infarction or vascular death among stroke survivors?
  • Does FDG PET can predict other important events such as fracture, dementia, bleeding, cancer and overall death among stroke survivors? Researchers will compare the FDG uptake in major organs - such as the amygdala, vertebrae, spleen, liver, internal carotid artery, visceral fat, and psoas muscle - between patients with and without the event of interest to determine whether FDG PET can predict the overall prognosis of stroke patients. Participants will:
  • Undergo whole-body FDG PET once their neurological status has stabilized after stroke.
  • Complete questionnaires assessing stress and anxiety (PHQ-9 and PSS-10) on the same day.
  • Maintain regular clinic visits for up to 24 months following the index stroke

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jun 2021Aug 2029

Study Start

First participant enrolled

June 22, 2021

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

7.7 years

First QC Date

June 19, 2025

Last Update Submit

June 19, 2025

Conditions

Keywords

cerebral infarction

Outcome Measures

Primary Outcomes (1)

  • Vascular events

    Stroke, myocardial infarction, vascular death

    up to 24 months after index stroke

Secondary Outcomes (1)

  • overall vascular events

    up to 24 months after index stroke

Other Outcomes (1)

  • Overall events

    up to 24 months after index stroke

Interventions

FDG-PETDIAGNOSTIC_TEST

The participants undergo whole-body FDG PET once their neurological status has stabilized after stroke.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 19 years and older who were diagnosed and treated for acute cerebral infarction within 7 days and can voluntarily participate in the study.

You may qualify if:

  • acute ischemic stroke patients who admitted within seven days after symptom onset

You may not qualify if:

  • Patients with unstable vital signs or neurological symptoms
  • Patients with estimated glomerular filtration rate less than 30ml/min
  • Patients with uncontrolled diabetes requiring persistent insulin injection
  • During pregnancy or while breastfeeding
  • Patients with impaired consent capacity
  • Patients with diagnosed/treatment for dementia
  • Patients undergoing treatment for malignant tumors or serious autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jong-ro Gu, 03080, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2025

First Posted

June 27, 2025

Study Start

June 22, 2021

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations