D001775 Clinical Trial
Official title:
Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods
NCT number | NCT04553484 |
Other study ID # | 35-0102 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 5, 2020 |
Est. completion date | January 14, 2022 |
Verified date | May 2022 |
Source | Semler Scientific |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aims of this study are to measure cardiovascular performance and blood flow using common but never compared methods.
Status | Completed |
Enrollment | 657 |
Est. completion date | January 14, 2022 |
Est. primary completion date | December 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | Inclusion Criteria: - At least 50 Patients from New York Heart Association (NYHA) Class 1 (One or more AHA Risk Factors, asymptomatic), =75% (36) Male, =25% (12) Female - At least 50 Patients from NYHA Class 2 (symptomatic), =75% (36) Male, =25% (12) Female Exclusion Criteria: - Subjects on mechanical ventilation. - Subjects who require decisions by a medical power of attorney. - Subjects unable to safely perform forced expiration. - Subjects with known technically difficult (TDS) trans-thoracic echocardiographic windows. |
Country | Name | City | State |
---|---|---|---|
United States | JF Southwest Heart Clinic, P.A. | Houston | Texas |
United States | Integrated Cardiology Group, LLC, d/b/a Bryan Heart | Lincoln | Nebraska |
United States | Middle Georgia Heart and Vascular Center | Macon | Georgia |
Lead Sponsor | Collaborator |
---|---|
Semler Scientific |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood flow measurement | A Clinician will use a fingertip sensor and expiration device to measure blood flow in a patient by Volume Plethysmography. | Baseline | |
Secondary | Cardiac performance measurement | A Cardiac Echo Technician will measure cardiac performance in a patient using Echocardiography. | through study completion, an average of 10 weeks |