A Study to Evaluate Remote Wearable-based Diagnosis of Postural Orthostatic Tachycardia Syndrome

Overview

Información sobre este estudio

The purpose of this study is to test the feasibility of using a novel wearable biosensor and mobile health monitoring platform to capture patients’ physiology, functional capacity and assessment of symptoms, thereby building a profile of Positional Orthostatic Tachycardia Syndrome (POTS) while excluding more serious cardiac, neurological and endocrine causes for their symptomatology. We hypothesize that as a non-fatal condition, a complete physiological profile of the POTS patients can be built entirely remotely therefore avoiding the need for these patients to visit the hospital and clinic.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria - POTS Confirmed Subjects:

Postural Orthostatic Tachycardia Syndrome (POTS) confirmed subjects are eligible to be included in the study only if all of the following criteria apply:

  • Presumed diagnosis of POTS and planned for evaluation and confirmatory testing in the Mayo Clinic POTS Innovation program.
  • Subjects has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age ≥ 18 to ≤ 40 years at signing of informed consent.

Inclusion Criteria - Control Subjects:

  • No diagnosis of POTS or suspicion for POTS.
  • Subjects has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age ≥ 18 to ≤ 40 years at signing of informed consent.

Exclusion Criteria:

All subjects are excluded from the study if any of the following criteria apply:

  • Refusal to sign informed consent.
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Christopher McLeod, M.B., Ch.B., Ph.D.

Cerrado para la inscripción

Contact information:

Erika Douglass M.P.H.

(904) 953-6595

Douglass.Erika@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20511388

Mayo Clinic Footer