Visualization of the Cerebral Arterial Circulation Using Contrast-Enhanced Transcranial Ultrasound in Code Stroke Patients

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

Ischemic stroke is a common, devastating and costly disease. A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain.
The purpose of this study is to visualize the blood vessels in the brain and to look for vessel occlusion (i.e., blockage) which may be the cause of stroke. Ultrasound contrast imaging may or may not improve the ability to diagnose vessel occlusion in the brain quickly and precisely, thereby expediting the therapy currently in place for acute stroke.
The contrast solutions used in this study have been approved by the Food and Drug Administration because they improve ultrasound pictures taken in the heart. While the solutions are approved for use with ultrasound in viewing the heart, the usefulness in viewing brain vessels has not been approved and is experimental.
The study will enroll 403 participants with possible diagnosis of acute stroke. Individuals participating in the study will be injected with a contrast solution via an intravenous line. A small probe will be used to obtain images of blood vessels in the head. The study researchers will measure vital signs prior to injection of the contrast solution, 5 minutes after the injection, and at the end of the ultrasound. Each participant will have a 5-minute mental function assessment and a brief neurological exam. Participants will undergo at least 3 ultrasounds. The total time of each ultrasound is less than 30 minutes.
This study is part of the Specialized Program of Translational Research in Acute Stroke to enhance and initiate translational research that ultimately will benefit stroke patients. Results from this study may help investigators learn about the future development of new diagnostic tests for stroke.

Conditions

Interventions

  • Ultrasound Device
    Intervention Desc: single intravenous administration of max. 1.5ml ultrasound contrast agent (Definity), followed by max. 15min transcranial insonation using diagnostic ultrasound.
    ARM 1: Kind: Experimental
    Label: 1
    Description: contrast-enhanced transcranial ultrasound to visualize the intracranial arteries

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

Individuals participating in the study will be injected with a contrast solution via an intravenous line. A small probe will be used to obtain images of blood vessels in the head. The study researchers will measure vital signs prior to injection of the contrast solution, 5 minutes after the injection, and at the end of the ultrasound. Each participant will have a 5-minute mental function assessment and a brief neurological exam. Participants will undergo at least 3 ultrasounds. The total time of each ultrasound is less than 30 minutes.

Outcomes

Type Measure Time Frame Safety Issue
Primary Sensitivity/specificity of contrast-enhanced transcranial ultrasound to assess MCA occlusion/patency within the first 24h after stroke onset, using MR-angiography as a gold standard.
Primary visualization of the intracranial arteries in comparison to reference method (MRA/CTA) within 24 hours No
Secondary Measure: vessel recanalization during/post tPA administration within 24 hours No
Secondary sensitivity/specificity, positive/negative predictive value of contrast-enhanced ultrasound in comparison to CTA/MRA baseline, 30min, 3h, 24h, day30 No

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