Trial Outcomes & Findings for Visualization of Cerebral Arteries Using Contrast-Enhanced Transcranial Ultrasound in Stroke Patients (NCT NCT00282841)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

within 24 hours after reference method

Results posted on

2019-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	All Stroke Code Patients 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 Study STARTED	61
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Stroke Code Patients n=61 Participants 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).
Age, Continuous	64.82 years n=93 Participants
Sex: Female, Male Female	27 Participants n=93 Participants
Sex: Female, Male Male	34 Participants n=93 Participants
Region of Enrollment United States	61 participants n=93 Participants

PRIMARY outcome

Timeframe: within 24 hours after reference method

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Stroke Code Patients - Reference Method n=488 number of vessel segments visualized 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).	Stroke Code Patients - Transcranial Ultrasound n=488 number of vessel segments visualized 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.
Number of Participants With Successful Visualization of the Intracranial Arteries in Comparison to Reference Method (MRA/CTA)	8 participants	8 participants

Adverse Events

Stroke Code Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thilo Hoelscher, MD

University of California San Diego

Phone: 619-543-5251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place