Assessment of Mast Cell Mediators in Pediatric Patients with Clinical Symptoms of Autonomic Dysfunction
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-002680
Sponsor Protocol Number: 15-002680
About this study
The purpose of this study is to determine if there are increases in mast cell mediators in subjects with autonomic dysfunction.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Pediatric patients (aged 8-18 years) with chronic symptoms (>3 months) symptoms of lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations, flushing, generalized puritis or dermatographism.
- Consent obtained from a responsible guardian AND from subjects 8-17 years of age OR consent obtained from subjects 18 years of age.
Exclusion Criteria:
- Previous diagnosis of a primary mast cell disorder (Systemic Mastocytosis or Monoclonal Mast Cell Activation Syndrome) or secondary mast cell activation disorder (IgE-mediated allergies).
- Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Amie Jones, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available