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Visualization of Cerebral Arteries Using Contrast-Enhanced Transcranial Ultrasound in Stroke Patients

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ClinicalTrials.gov Identifier: NCT00282841
Recruitment Status : Terminated (Study terminated due to slow recruitment and funding ended.)
First Posted : January 27, 2006
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of California, San Diego

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Stroke
Intervention Other: ultrasound
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Stroke Code Patients
Hide Arm/Group Description Patients admitted with acute stroke code whether or not they will undergo thrombolytic therapy who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA).
Period Title: Overall Study
Started 61 [1]
Completed 61
Not Completed 0
[1]
Anticipated recruitment 400; stopped due to funding and poor recruitment.
Arm/Group Title All Stroke Code Patients
Hide Arm/Group Description Patients admitted with acute stroke code whether or not they will undergo thrombolytic therapy who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA).
Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 61 participants
64.82
(34 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
27
  44.3%
Male
34
  55.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 61 participants
61
1.Primary Outcome
Title Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA)
Hide Description 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.
Time Frame within 24 hours after reference method
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the assumption that all target intracranial vessel segments could be visualized with either one of the reference methods, CTA or MRA, in all patients enrolled, the transcranial ultrasound data was analyzed to assess how many of the target vessel segments could be visualized in comparison to the reference method.
Arm/Group Title Stroke Code Patients - Reference Method Stroke Code Patients - Transcranial Ultrasound
Hide Arm/Group Description:
Patients admitted with acute stroke code whether or not they will undergo thrombolytic therapy who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA).
All acute stroke patients who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA) did receive a contrast-enhanced transcranial ultrasound study as well.
Overall Number of Participants Analyzed 61 61
Overall Number of Units Analyzed
Type of Units Analyzed: Number of vessel segments visualized
488 488
Measure Type: Number
Unit of Measure: participants
8 8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stroke Code Patients
Hide Arm/Group Description Patients admitted with acute stroke code whether or not they will undergo thrombolytic therapy who received magnetic resonance angiography (MRA) or computerized tomographic angiography (CTA).
All-Cause Mortality
Stroke Code Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stroke Code Patients
Affected / at Risk (%)
Total   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stroke Code Patients
Affected / at Risk (%)
Total   0/61 (0.00%) 
Early termination leading to small numbers of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thilo Hoelscher, MD
Organization: University of California San Diego
Phone: 619-543-5251
EMail: thoelscher@ucsd.edu
Layout table for additonal information
Responsible Party: University of California, San Diego
ClinicalTrials.gov Identifier: NCT00282841     History of Changes
Other Study ID Numbers: P50NS44148MATTREY
P50NS044148-06 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2006
First Posted: January 27, 2006
Results First Submitted: September 27, 2010
Results First Posted: August 7, 2019
Last Update Posted: August 7, 2019