A Study of Cardiopulmonary Exercise Heart Sound S1
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: 18-008458
Sponsor Protocol Number: 90d0193
About this study
The purpose of this study is to evaluate the ability to determine the first heart sound (S1) and its relationship to aerobic capacity.
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:
Cohort A
- Subjects without diagnosis of cardiovascular disease, including coronary artery disease, myocardial infarction and heart failure.
- Age 18 years or older on the day of screening.
- Agreeable to wear the WCD.
Cohort B
- Subjects with history of heart failure and at least one prevoius heart failure hospitalization.
- Age 18 years or older on the day of screening.
- Agreeable to wear the WCD.
Exclusion Criteria:
Absolute Contraindication to Exercise Testing
- Acute myocardial infarction (within 2 days).
- Unstable angina not previously stabilized by medical therapy.
- Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.
- Symptomatic severe aortic stenosis.
- Uncontrolled symptomatic heart failure.
- Acute pulmonary embolus or pulmonary infarction.
- Acute myocarditis or pericarditis.
- Acute aortic dissection.
Relative Contraindication to Exercise Testing
- Left main coronary stenosis.
- Moderate stenotic valvuar heart disease.
- Electrolyte abnormalities.
- Severe arterial hypertension.
- Tachyarrhythmias or bradyarrhythmias.
- Hypertrophic cardiomyopathy and other forms of outflow tract obstruction.
- Mental or physical impairment leading to inability to exercise adequately.
- High-degree atrioventricular block.
- Advance or complicated pregnancy.
Other Reasons for Exclusion
- Subjects with a pacemaker dependent rhythm, including implanted pacemaker or CRT.
- Subjects having a chest circumference over 56 inches (142 cm) or under 26 inches (66 cm).
- Subjects unable or unwilling to provide informed consent.
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 Bruce Johnson, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available