Comparison of Different Non-invasive Methods to Assess Pulse Wave Analysis (MULTI-PWA)

May 8, 2023 updated by: University Medicine Greifswald

Vergleich Verschiedener Nicht-invasiver Verfahren Zur Pulswellenanalyse

The primary goal of the study is to compare different methods for pulse wave measurement and analysis which are cuffless and contactless. The novel measurement tools will be compared to cuff-based reference methods.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, 17489
        • Recruiting
        • Cardiovascular examination center of the University Medicine Greifswald
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

general population

Description

Inclusion Criteria:

  • older than 18 years
  • male or female sex
  • signed informed consent.

Exclusion Criteria:

  • acute sickness which influences hemodynamic parameters
  • arm circumference is below or above the limits for the blood pressure of the reference method (i.e. below 20 or above 40 cm)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with sinus rhythm
Device: Pulse wave measurement and analysis
Different contact-less and cuff-less pulse wave measurements will be used and compared to cuff-based reference method.
Participants with atrial fibrillation
Device: Pulse wave measurement and analysis
Different contact-less and cuff-less pulse wave measurements will be used and compared to cuff-based reference method.
Participants with extra systoles
Device: Pulse wave measurement and analysis
Different contact-less and cuff-less pulse wave measurements will be used and compared to cuff-based reference method.
Participants with heart failure with reduced ejection fraction
Device: Pulse wave measurement and analysis
Different contact-less and cuff-less pulse wave measurements will be used and compared to cuff-based reference method.
Participants with mildly reduced or preserved ejection fraction
Device: Pulse wave measurement and analysis
Different contact-less and cuff-less pulse wave measurements will be used and compared to cuff-based reference method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and diastolic blood pressure
Time Frame: 3 months
Cuffless and contactless methods will be used to measure and analyze pulse wave velocity to estimate systolic and diastolic blood pressure
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 10, 2023

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202103Multi-PWA

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Pressure

Clinical Trials on Pulse wave measurement and analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe