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

Completed

• Conditions: D001775; D012039
• Interventions: Diagnostic Test: No intervention

• Registration Number: NCT04553484
• Lead Sponsor: Semler Scientific

Brief Summary

Measuring Cardiovascular Performance Using Common Methods in subjects.

Detailed Description

This study will conduct measurements of cardiovascular performance by echocardiography (Echo), Brain Natriuretic Peptide (BNP) blood serum levels and blood flow by volume plethysmography (VP) in subjects who meet the AHA/ACC criteria for screening for peripheral arterial disease (PAD).

Study Timeline

• Study Start: 2020-08-05
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-17
• Primary Completion: 2021-12-29
• Study Completion: 2022-01-14
• Results First Submitted: 2022-12-28
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Results First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 657

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects enrolled	No intervention	The feasibility of conducting all three tests, echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), on all subjects met the enrollment criteria.

Primary Outcome Measures

Name	Time	Method
Feasibility of Performing Echo, BNP, and VP on Human Subjects.	Baseline	The feasibility of performing three common tests, Echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), in the same subject was assessed. Each of the 657 participants were submitted to a brief non-invasive blood flow and cardiac performance test (plethysmography (VP) and Echocardiography (Echo)). Each of the 236 participants were subject to blood drawn test, Brain Natriuretic Peptide (BNP).

Trial Locations

Locations (4)

Middle Georgia Heart and Vascular Center; 🇺🇸 Macon, Georgia, United States

JF Southwest Heart Clinic, P.A.; 🇺🇸 Houston, Texas, United States

Southwest Clinical Trials; 🇺🇸 Houston, Texas, United States

Integrated Cardiology Group, LLC, d/b/a Bryan Heart; 🇺🇸 Lincoln, Nebraska, United States