24-hour Blood Pressure Measurements and Ischemic Conditioning

NCT03303404 | Completed Results FDA Device

• 1 other identifier: 2017-07-0043
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if 24-hr ambulatory blood pressure monitoring effects endothelial function, we will measure flow-mediated dilation before and after the blood pressure monitoring (ischemia conditioning).

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Flow Mediated Dilation After 24 Hour Ischemic Conditioning With Blood Pressure Cuff

  Flow-mediated dilatation (FMD) is a common and non-invasive method to assess vascular endothelial function by measuring the Brachial artery's responsiveness (diameter percent increase) following a brief period of occlusion.

  Baseline, Post 24 hour conditioning

Study Arms (1)

Ambulatory (24-hour) Blood Pressure

EXPERIMENTAL

Device: Ambulatory (24-hour) Blood Pressure

Interventions

Ambulatory (24-hour) Blood Pressure DEVICE

Unlike casual blood pressure measurements, 24-hour ambulatory blood pressure monitoring provides an insight into blood pressure changes in everyday life and an estimate of the overall blood pressure load exerted on the cardiovascular system over 24 hours. Blood pressure recordings over a 24-hour period of normal daily activity will be made using a noninvasive ambulatory monitor (Spacelabs, Redlands, WA). The ambulatory system will be calibrated against a mercury sphygmomanometer, and the cuff will be programmed to inflate automatically every 15 min from 6 AM to 11 PM and every 20 min between 11 PM and 6 AM. For each individual subject, the nighttime period will be defined as the time when the subject goes to bed at night until rising in the morning. Daytime will be defined as the remainder of the 24-hour period. Daytime and nighttime states will be monitored by an Actiwatch (Mini-MItter, Bend, OR), a watch-like device placed on the wrist that measures gross motor activity.

Ambulatory (24-hour) Blood Pressure

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged between 30 to 60 years old.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dr. Hirofumi Tanaka

Austin, Texas, 78713, United States

Location

Related Publications (1)

• Fico BG, Zhu W, Tanaka H. Does 24-h ambulatory blood pressure monitoring act as ischemic preconditioning and influence endothelial function? J Hum Hypertens. 2019 Nov;33(11):817-820. doi: 10.1038/s41371-019-0214-y. Epub 2019 Jun 27.

  PMID: 31249371 DERIVED

MeSH Terms

Interventions

Blood Pressure

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Brandon Fico
• Organization: University of Texas at Austin

bfico@utexas.edu

512-471-8594

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 6, 2017
• Study Start: September 12, 2017
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: December 22, 2020
• Results First Posted: December 22, 2020

Record last verified: 2020-12

Locations

US (1)