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

Sponsor

University Medicine Greifswald (Other)

Overall Status

Recruiting

CT.gov ID

NCT05790642

Collaborator

(none)

225

Enrollment

Location

17.1

Anticipated Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure Arterial Stiffness Arrythmia	Device: Pulse wave measurement and analysis

Study Design

Study Type:

Observational

Anticipated Enrollment :

225 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Vergleich Verschiedener Nicht-invasiver Verfahren Zur Pulswellenanalyse

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

Systolic and diastolic blood pressure [3 months]
Cuffless and contactless methods will be used to measure and analyze pulse wave velocity to estimate systolic and diastolic blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular examination center of the University Medicine Greifswald	Greifswald		Germany	17489

Sponsors and Collaborators

University Medicine Greifswald

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Medicine Greifswald

ClinicalTrials.gov Identifier:

NCT05790642

Other Study ID Numbers:

202103Multi-PWA

First Posted:

Mar 30, 2023

Last Update Posted:

Mar 30, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Study Results

No Results Posted as of Mar 30, 2023