Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT06368193
Eligibility Criteria:
1. Male or female age ≥ 22 years
2. Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
3. 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
4. Admitted with a stroke or TIA attributed to large artery occlusion or severe stenosis that has not been revascularized.
Exclusion Criteria: (all must be no)
1. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
2. 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
3. Above the wrist amputation
4. Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
5. Currently imprisoned
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06368193
Study Brief:
Protocol Section:
NCT06368193