Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods

The aims of this study are to measure cardiovascular performance and blood flow using common but never compared methods.

Study Overview

• Status: Completed
• Conditions: D012039; D001775
• Intervention / Treatment: Diagnostic test: Measuring cardiovascular performance and blood flow

• Study Type: Interventional
• Enrollment (Actual): 657
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Macon, Georgia, United States, 31210
      • Middle Georgia Heart and Vascular Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Integrated Cardiology Group, LLC, d/b/a Bryan Heart
  • Texas
    • Houston, Texas, United States, 77072
      • JF Southwest Heart Clinic, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Measuring cardiovascular performance and blood flow	Diagnostic test: Measuring cardiovascular performance and blood flow; Measuring cardiovascular performance and blood flow; Other Names: Echocardiography; Expiration Device; QuantaFlo Sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac performance measurement	A Cardiac Echo Technician will measure cardiac performance in a patient using Echocardiography.	through study completion, an average of 10 weeks

Collaborators and Investigators

• Sponsor: Semler Scientific
• Investigators: Study Director: Jim Kermode, Semler Scientific

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Actual): December 29, 2021
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 35-0102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No