A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S. (CATCH-US)

February 3, 2025 updated by: Nucor

A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S.: a Prospective Single-center Observational Clinical Study.

To screen for and identify subjects with potential undiagnosed hypertension using an optical blood pressure monitoring device across an active workforce population in the US (Nucor employees).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

100 voluntary Nucor facility employees with no previous diagnosis of hypertension will be recruited and will receive an optical blood pressure monitoring device (Aktiia G1 Device) that is a miniature bracelet placed in the wrist and measure blood pressure continuously without inflating.

Each participant will wear the device continually during 28 days.

Study Type

Observational

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

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Nucor

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A total of 100 subjects aged 25 to 70 years old who do not have a known diagnosis of hypertension and are employed at the Nucor Corp facility.

Description

Inclusion Criteria:

  1. Adult subjects aged 25 to 70 years old.
  2. People who self-report that they do not have a diagnosis of hypertension.
  3. People employed as a Nucor team member.
  4. People who can read and speak English.
  5. People who use either an iOS or Android smart phone.
  6. Subjects who agree to follow study procedures.
  7. Subjects who have signed the informed consent form.

Exclusion Criteria:

  1. Subjects with a known diagnosis of i. atrial fibrillation ii. congestive heart failure iii. heart valve disease iv. pheochromocytoma v. Raynaud's disease vi. arm lymphedema.
  2. Subjects who take insulin.
  3. Subjects who are on hemodialysis.
  4. Women who are known to be pregnant.
  5. Subjects whose arms shake uncontrollably or are paralyzed (cannot move).
  6. Subjects who do not have two arms.
  7. Subjects with upper arm circumference < 22cm or > 42cm.
  8. Subjects with wrist circumference > 23cm.

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
CATCH-US cohort
Non-hypertensive Nucor employees that accept to receive and wear continuously for 28 days an optical blood pressure monitoring device (Aktiia 24/7 device)
Device: Optical Blood Pressure Monitoring Device (Aktiia G1)

Non-hypertensive Nucor employees that accept to wear an optical blood pressure monitoring device (Aktiia 24/7 device) to screen for and identify potential undiagnosed hypertension.

100 participants. Each participant will wear the device continuously for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of subjects with undiagnosed hypertension
Time Frame: Each participant will wear the device continuously for 28 days.
Analysis of the percentage of subjects with undiagnosed hypertension defined as an average daytime SBP>130 or DBP>80 mmHg over the initial 7 days of the Aktiia 24/7 device use.
Each participant will wear the device continuously for 28 days.

Collaborators and Investigators

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

Sponsor

Nucor

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 (Estimated)

January 16, 2025

Primary Completion (Estimated)

July 16, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CATCH-US

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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