24-hour Blood Pressure Measurements and Ischemic Conditioning

Blood Pressure Clinical Trial

Official title:

24-hour Blood Pressure Measurements and Ischemic Conditioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03303404
• Other study ID #: 2017-07-0043
• Status: Completed
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: September 20, 2018

Study information

• Verified date: December 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Reestablishing blood flow (reperfusion) to organs that had their blood supply restricted (ischemia) can cause damage to the vasculature via injury and tissue death resulting in endothelial dysfunction. This ischemia-reperfusion (blood flow occlusion and resupply) triggered injury can be reduced or prevented by preceding brief periods of ischemia called preconditioning. Properly-performed preconditioning can exert a powerful protection against a subsequent sustained period of ischemia in a variety of organs in the body including the heart, kidney, and skeletal muscle. Preconditioning protocol involves repeated brief inflation and deflation of a blood pressure cuff. In many of human cardiovascular research studies, it is common to measure endothelial function and ambulatory (24-hour) blood pressure. The ambulatory blood pressure device takes repeated blood pressure readings every 15-30 minutes during the daytime and 30-60 minutes at night. It is possible that repeated bouts of inflation/deflation of the blood pressure cuff could induce preconditioning effects and influence endothelial function. Therefore, in the proposed study we aim to address this hypothesis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 20, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

Adults aged between 30 to 60 years old.

Exclusion Criteria:

Exclusion from the study may be due to: i) pregnancy (by asking the subjects when the last time she had menstruation; we do have simple testing kits available if a subject is unsure about her status); ii) a recent illness, recent surgery, or any medical intervention in the 48 hours before any of the study days; iii) personal history of diabetes (fasting blood glucose > 126 mg/dL), heart disease, or other cardiovascular problems.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• Ambulatory (24-hour) Blood Pressure
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.

Locations

Country	Name	City	State
United States	Dr. Hirofumi Tanaka	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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