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

NCT ID: NCT04553484

Last Updated: 2024-07-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

657 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-05

Study Completion Date

2022-01-14

Brief Summary

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Measuring Cardiovascular Performance Using Common Methods in subjects.

Detailed Description

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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).

Conditions

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D012039 D001775

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All subjects enrolled

The feasibility of conducting all three tests, echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), on all subjects met the enrollment criteria.

No intervention

Intervention Type DIAGNOSTIC_TEST

No intervention

Interventions

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No intervention

No intervention

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semler Scientific

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jim Kermode

Role: STUDY_DIRECTOR

Semler Scientific

Locations

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Middle Georgia Heart and Vascular Center

Macon, Georgia, United States

Site Status

Integrated Cardiology Group, LLC, d/b/a Bryan Heart

Lincoln, Nebraska, United States

Site Status

JF Southwest Heart Clinic, P.A.

Houston, Texas, United States

Site Status

Southwest Clinical Trials

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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35-0102

Identifier Type: -

Identifier Source: org_study_id

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