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New treatment option for Stroke
Official title The Neuralert Stroke Monitor Pilot Trial
ClinicalTrials.gov ID: NCT06368193
What this study is testing
- What it's testing
- This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Male or female age ≥ 22 years
- Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
- Considered at high risk for stroke while in the hospital based on: Ø Interventions or procedures that are high-risk for stroke performed during the...
- Intracardiac surgical or endovascular procedures, including valve replacement
- Ascending aorta or aortic arch surgical or endovascular repair
You likely can't join if
- (all must be no)
- Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation...
- Baseline preoperative asymmetric upper extremity weakness as assessed by the Investigator, defined as a differential in the NIHSS upper extremity...
- Above the wrist amputation
- Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
- Currently imprisoned
See the full eligibility criteria
- Male or female age ≥ 22 years
- Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
- Considered at high risk for stroke while in the hospital based on: Ø Interventions or procedures that are high-risk for stroke performed during the hospitalization, which may include:
- Intracardiac surgical or endovascular procedures, including valve replacement
- Ascending aorta or aortic arch surgical or endovascular repair
- Open surgical or endovascular carotid revascularization Ø Other cardiac procedures along with a high-risk medical history:
- Age ≥ 80 years Prior stroke/TIA
- Hypercoagulable state (i.e., prior clotting events attributed to active malignancy or a diagnosed thrombophilia) requiring lifelong anticoagulation
- Severely reduced left ventricular cardiac ejection fraction (i.e., \<30%) or anterior left ventricular wall akinesis
- Atrial fibrillation
- Admitted with a stroke or TIA attributed to large artery occlusion or severe stenosis that has not been revascularized.
- (all must be no)
- Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
- Baseline preoperative asymmetric upper extremity weakness as assessed by the Investigator, defined as a differential in the NIHSS upper extremity motor score between the two arms of \>0
- Above the wrist amputation
- Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
- Currently imprisoned
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.