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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT03761394
Eligibility Criteria:
Inclusion Criteria:
* History of Transient Ischemic Attack (TIA) or stroke or at risk for stroke based on a CHA2DS2-VASc score equal to or greater to a score of 3, presenting at the UMass Memorial Medical Center (UMMMC) inpatient service or ambulatory clinic (neurology clinics and cardiovascular clinics included)
* Age: greater to or equal to 50 years of age
* Able to sign informed consent
* Willing to participant in a focus groups and/or Hack-a-thon for Aim 1 participants only
* Willing and capable of using Pulsewatch (smartwatch and smartphone app) daily for up to 44-days and returning to UMMMC for up to two study visits for Aims 2 and 3 participants only
Exclusion Criteria:
* Major contraindication to anti-coagulation treatment
* Plans to move our of the area over the 44-day follow up period
* Serious physical illness (e.g., unable to interact with a smart device, or communicate verbally or via written text) that would interfere with study participation
* Known allergies or hypersensitivities to medical grade hydrocolloid adhesives or hydrogel
* Patient with life threatening arrhythmia's who require in-patient monitoring for immediate analysis
* Patient with implantable pacemaker as paced beats interfere with ECG readings
* Lacking capacity to sign informed consent
* Unable to read and write in English
* Plans to move from the area during the study period
* Unwilling to complete all study procedures
* Major contraindication to anti-coagulation treatment (i.e., major hemorrhagic stroke)
* Individuals who are not yet adults
* Pregnant women
* Prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
100 Years
Study:
NCT03761394
Study Brief:
Protocol Section:
NCT03761394