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

Nucor

Status: Withdrawn

Conditions: Hypertension

Treatments: Device: Optical Blood Pressure Monitoring Device (Aktiia G1)

Study type: Observational

Funder types: Industry

Identifiers

NCT06721611

CATCH-US

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

CATCH-US cohort

Description:

Non-hypertensive Nucor employees that accept to receive and wear continuously for 28 days an optical blood pressure monitoring device (Aktiia 24/7 device)

Treatment:

Device: Optical Blood Pressure Monitoring Device (Aktiia G1)