NCT02077582

Brief Summary

The objective of this trial is to visualize blood brain barrier function and metabolic changes in the first days after ischemic stroke with new investigational MRI sequences.

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
410

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

5 years

First QC Date

February 23, 2014

Last Update Submit

March 3, 2014

Conditions

Cerebral Stroke

Keywords

acute ischemic stroke

Outcome Measures

Primary Outcomes (2)

  • clinical outcome measured with the National Institutes of Health Stroke Scale (NIHSS)

    on follow-up examination day 5-7

  • clinical outcome measured with the modified Rankin Scale (mRS)

    conducted as telephone interview

    on day 90

Secondary Outcomes (1)

  • final lesion volume (measured on FLAIR images)

    on follow-up examination day 5-7

Other Outcomes (4)

  • volumes of hypoperfusion on resting state-MRI perfusion maps

    on follow-up examinations day 1 and 2

  • blood flow parameters in occluded, contralateral and (partially) recanalized vessels

    on follow-up examinations day 1 and 2

  • pH values in the region of diffusion restriction and in the region of final infarct

    on follow-up examinations day 1 and 2

  • +1 more other outcomes

Eligibility Criteria

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

Primary care clinic. Patients presenting with acute (\<24h) transient ischemic attack or stroke at the emergency ward, Charité Campus Benjamin Franklin

You may qualify if:

  • Suspected stroke or transient ischemic attack (TIA) within 24h from symptom onset

You may not qualify if:

  • MRI contraindication, age \< 18 years, intracranial hemorrhages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, State of Berlin, 12203, Germany

RECRUITING

Related Publications (5)

  • Fan AP, Khalil AA, Fiebach JB, Zaharchuk G, Villringer A, Villringer K, Gauthier CJ. Elevated brain oxygen extraction fraction measured by MRI susceptibility relates to perfusion status in acute ischemic stroke. J Cereb Blood Flow Metab. 2020 Mar;40(3):539-551. doi: 10.1177/0271678X19827944. Epub 2019 Feb 7.

    PMID: 30732551DERIVED

  • Villringer K, Florczak-Rzepka M, Grittner U, Brunecker P, Tepe H, Nolte CH, Fiebach JB. Characteristics associated with outcome in patients with first-ever posterior fossa stroke. Eur J Neurol. 2018 Jun;25(6):818-824. doi: 10.1111/ene.13596. Epub 2018 Mar 25.

    PMID: 29431878DERIVED

  • Ganeshan R, Nave AH, Scheitz JF, Schindlbeck KA, Haeusler KG, Nolte CH, Villringer K, Fiebach JB. Assessment of thrombus length in acute ischemic stroke by post-contrast magnetic resonance angiography. J Neurointerv Surg. 2018 Aug;10(8):756-760. doi: 10.1136/neurintsurg-2017-013454. Epub 2017 Nov 18.

    PMID: 29151041DERIVED

  • Khalil AA, Ostwaldt AC, Nierhaus T, Ganeshan R, Audebert HJ, Villringer K, Villringer A, Fiebach JB. Relationship Between Changes in the Temporal Dynamics of the Blood-Oxygen-Level-Dependent Signal and Hypoperfusion in Acute Ischemic Stroke. Stroke. 2017 Apr;48(4):925-931. doi: 10.1161/STROKEAHA.116.015566. Epub 2017 Mar 8.

    PMID: 28275197DERIVED

  • Villringer K, Sanz Cuesta BE, Ostwaldt AC, Grittner U, Brunecker P, Khalil AA, Schindler K, Eisenblatter O, Audebert H, Fiebach JB. DCE-MRI blood-brain barrier assessment in acute ischemic stroke. Neurology. 2017 Jan 31;88(5):433-440. doi: 10.1212/WNL.0000000000003566. Epub 2016 Dec 28.

    PMID: 28031392DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

2x 2ml plasma and 2x 2ml serum per patient

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Jochen B: Fiebach, MD

CONTACT

004930 8445 4088jochen.fiebach@charite.de

Kersten Villringer, MD

CONTACT

004930 8445 4080kersten.villringer@charite.de

Study Design

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

Study Record Dates

First Submitted

February 23, 2014

First Posted

March 4, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

DE(1)