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RECRUITING

Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data

Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data - A Cross-sectional Study in Apparently Healthy Women Aged 40 to 69 Years (Frauenherzen)

NCT06831890•Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

Summary

The goal of the clinical trial is to assess whether the data collected from wearable devices can reduce the uncertainty in predicting the cardiovascular disease (CVD) risk in women aged 40-69 years in a situation where information about the blood pressure and blood lipids are unavailable. Participants will: * Complete a screening and baseline assessment, including blood sample collection and vital parameter measurement. * Wear a wearable device for one week. * Fill in a work and sleep journal. * Complete a last visit assessment.

Eligibility

Age

40 - 69 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Fluency in German (written and oral).
•Ownership of a smartphone.
•Signing the informed consent form.

Exclusion Criteria

•Diagnosis of cardiovascular disease.
•Diagnosis of diabetes mellitus.
•Diagnosis of chronic kidney disease.
•Diagnosis of familial hypercholesterolemia.
•Incapable of providing informed consent.
•Current employment at the Section Gynecological Endocrinology and Reproductive Medicine of the Department for Obstetrics and Gynecology at the Inselspital Bern or any other professional relation to one of the study project leaders / investigators.
•Concurrent participation in a clinical intervention study.
•Inability to comply with the study procedures for any reason, including language comprehension, psychiatric illness, general inability to get to the study site.
•Participant's smartphone not compatible with Fitrockr.
•Technical inability of participant's smartphone to connect to the smartwatch.

Locations (1)

University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

Bern, Switzerland

Key Dates

Start Date

August 24, 2023

Primary Completion Date

March 1, 2025

Completion Date

March 1, 2025

Last Updated

February 18, 2025

Enrollment

250

ESTIMATED participants

Conditions

Cardiovascular DiseasesMenopause

Contacts

Petra Stute, Prof.

CONTACT

+41 31 632 1010 petra.stute@insel.ch

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data

Inclusion Criteria

Exclusion Criteria

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