NCT02024503

Brief Summary

Imaging of the ischaemic penumbra with a particular diffusion-weighted imaging (DWI)/ perfusion-weighted imaging (PWI) mismatch is a promising approach to the selection of patients with acute ischaemic stroke for trials of intervention. The investigators want to apply multimodal resonance imaging methods such as functional magnetic resonance imaging ( fMRI), diffusion tensor imaging (DTI), arterial spin labeling (ASL) to guide treatment and predict the prognosis of stroke.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

1.7 years

First QC Date

December 25, 2013

Last Update Submit

December 30, 2013

Conditions

Keywords

strokefMRIDTI

Outcome Measures

Primary Outcomes (1)

  • Functional recovery

    Participants will be followed till die or lost to follow-up,an expected average of three year.

Secondary Outcomes (1)

  • Over survival

    Participants will be followed till die or lost to follow-up,an expected average of three year

Study Arms (2)

Experimental group

Hospitalized patients with acute stroke.

Control group

Healthy Volunteers.

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients with stroke and the some healthy volunteers recruited from community

You may qualify if:

  • Time from the onset of stroke till hospital within 24 hours. With clinical characteristics such as hemiplegia, headache. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
  • Patients must understand the nature of the study and give informed consent.

You may not qualify if:

  • The onset of stroke out of 24 hours. Pregnant women. Patients with intracranial metallic bodies from prior neurosurgical procedure, implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit or ventriculoperitoneal shunt.
  • Past history of seizures within one year or unexplained loss of consciousness. Family history of epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Extraction of DNA from the blood of patients.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gao-jun Teng, Ph.D,MD

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-yu Peng

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology & Chair,Department of Radiology

Study Record Dates

First Submitted

December 25, 2013

First Posted

December 31, 2013

Study Start

September 1, 2013

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations