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

NCT06721611 | Withdrawn

• 1 other identifier: CATCH-US
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hypertension

Keywords

hypertension; blood pressure

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects with undiagnosed hypertension

  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.

Study Arms (1)

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)

Interventions

Optical Blood Pressure Monitoring Device (Aktiia G1) DEVICE

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.

CATCH-US cohort

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.
• Subjects who take insulin.
• Subjects who are on hemodialysis.
• Women who are known to be pregnant.
• Subjects whose arms shake uncontrollably or are paralyzed (cannot move).
• Subjects who do not have two arms.
• Subjects with upper arm circumference \< 22cm or \> 42cm.
• Subjects with wrist circumference \> 23cm.

Sponsors & Collaborators

• Nucor: lead

Study Sites (1)

Nucor

Charlotte, North Carolina, 28211, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: January 16, 2025
• Primary Completion: July 16, 2025
• Study Completion: August 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

US (1)