NCT02580097

Brief Summary

To explore prediction model for outcome of patients with acute ischemic stroke using multimodal Magnetic Resonance(MR) imaging was a multicenter prospective observational study supported by National Natural Science Foundation of China. Imaging evaluation of hemodynamic status and antegrade flow were assessed. Patients were followed up to record radiological and clinical outcome. The study recruited patients from 11 centers located in 10 provinces or province-level municipalities across the northeast to the southeast of China mainland.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
961

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

5.4 years

First QC Date

October 16, 2015

Last Update Submit

August 26, 2021

Conditions

Stroke

Keywords

Arterial Spin LabelingIschemic strokeCollateral CirculationPerfusion imaging

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Score

    Modified Rankin Score of patients with acute stroke after 3 months will be followed up for neurological outcome assessment. mRS \< 2 is defined as favorable

    Three months

Secondary Outcomes (3)

  • Final infarct volume

    Seven days to 1 month

  • Stroke event

    within 1 year

  • mortality

    within 1 year

Study Arms (1)

Stroke

Ischemic stroke patients with sympton onset in 24 hours and no contradiction to MRI scan

Other: MRI

Interventions

MRIOTHER

MRI perfusion imaging, including contrast bolus perfusion imaging and arterial spin labeling.

Stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ischemic stroke patients with sympton onset in 24 hours

You may qualify if:

  • age≥18
  • Cerebral ischemic sympton with onset in 24 hours
  • pre mRS\<2
  • All MR examination performed according to study protocol
  • Signed informed consent obtained from the patient or patient's legally authorized representative
  • Having complete medical history and clinical follow up
  • Imaging data can be processed

You may not qualify if:

  • Intracranial hemorrhage
  • Pregnancy and other contraindication to MRI scan
  • Informed consent not obtained
  • Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
  • Known allergy to iodine previously refractory to pretreatment medications
  • Renal Failure (serum creatinine \> 2.0 or Glomerular Filtration Rate \[GFR\] \< 30)
  • History of sever kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure
  • Severe cardiac insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

  • Lyu J, Xiao S, Meng Z, Wu X, Chen W, Wang G, Niu Q, Li X, Bian Y, Han D, Guo W, Yang S, Bian X, Duan Q, Lan Y, Wang L, Zhang T, Duan C, Chen L, Tian C, Pan Y, Zhou X, Lou X; MR-STARS Investigators. Collateral-Core Ratio as a Novel Predictor of Clinical Outcomes in Acute Ischemic Stroke. Transl Stroke Res. 2023 Feb;14(1):73-82. doi: 10.1007/s12975-022-01066-9. Epub 2022 Jul 25.

    PMID: 35877061DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xin Lou, M.D.,Ph.D.

    Chinese PLA General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief of Radiology

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 20, 2015

Study Start

August 1, 2015

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

CN(1)