NCT00282841

Brief Summary

The purpose of this study is to find out more about the usefulness of ultrasound in combination with a contrast solution to look for blood vessel blockage or occlusion in the brains of stroke patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
terminated

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

March 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
11.9 years until next milestone

Results Posted

Study results publicly available

August 7, 2019

Completed
Last Updated

August 7, 2019

Status Verified

July 1, 2019

Enrollment Period

2.6 years

First QC Date

January 26, 2006

Results QC Date

September 27, 2010

Last Update Submit

July 18, 2019

Conditions

Stroke

Keywords

strokeultrasoundocclusionblockagecontrast solution

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA)

    The number of participants with successful visualization (yes/no) of the cerebral artery segments was assessed by an experienced sonographer who was blinded to the cerebral MRA/CTA.

    within 24 hours after reference method

Study Arms (1)

All stroke code patients

EXPERIMENTAL

After written informed consent Code Stroke patients will undergo a contrast-enhanced transcranial ultrasound study to visualize the intracranial arteries. To do so, an ultrasound contrast agent (Definity) will be administered intravenously and transcranial ultrasound will be applied via the temporal bone window on both sides. Goal is to visualize and assess the intracranial arteries bilaterally. This includes the following vessel segments on both sides: middle cerebral artery (M1,M2,M3 segments), anterior cerebral artery (A1,A2 segments), posterior cerebral artery (P1,P2 segments), internal carotid artery (C1/2,C3/4 segments).

Other: ultrasound

Interventions

ultrasoundOTHER

single intravenous administration of maximum 1.5 milliliter ultrasound contrast agent (Definity), followed by maximum 15 minutes transcranial insonation using diagnostic ultrasound.

Also known as: Doppler
All stroke code patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient 18 years of age or older
  • code stroke patient

You may not qualify if:

  • women with positive pregnancy test
  • women who are breast feeding
  • severe emphysema
  • pulmonary vasculitis
  • history of pulmonary emboli
  • chronic renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Diego Hillcrest Medical Center

San Diego, California, 92101, United States

Location

Sharp Memorial Hospital, 7901 Frost Street

San Diego, California, 92103-8756, United States

Location

Related Publications (1)

  • Holscher T, Sattin JA, Raman R, Wilkening W, Fanale CV, Olson SE, Mattrey RF, Lyden PD. Real-time cerebral angiography: sensitivity of a new contrast-specific ultrasound technique. AJNR Am J Neuroradiol. 2007 Apr;28(4):635-9.

    PMID: 17416812BACKGROUND

MeSH Terms

Conditions

StrokeBites and Stings

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

Title
Thilo Hoelscher, MD
Organization
University of California San Diego
thoelscher@ucsd.edu
619-543-5251

Study Officials

  • Robert Mattrey, MD

    UCSD Stroke Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 27, 2006

Study Start

March 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

August 7, 2019

Results First Posted

August 7, 2019

Record last verified: 2019-07

Locations

US(2)