Blood PressureNCT03303404
24-hour Blood Pressure Measurements and Ischemic Conditioning
A study testing Ambulatory (24-hour) Blood Pressure in people with Blood Pressure, run by University of Texas at Austin at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Ambulatory (24-hour) Blood Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2017to 20 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged between 30 to 60 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed 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.
- Conditions
- Blood Pressure
- Being tested
- Ambulatory (24-hour) Blood Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory (24-hour) Blood PressureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory (24-hour) Blood Pressure | Experimental | Not described Receives: Device: Ambulatory (24-hour) Blood Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Post 24 hour conditioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start12 Sep 2017
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303404
- Sponsor's protocol ID
- 2017-07-0043
- Status last verified
- Dec 2020
- First submitted
- 2 Oct 2017
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 31249371
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-hour Blood Pressure Measurements and Ischemic Conditioning
- ClinicalTrials.gov ID
- NCT03303404
- Acronym / sponsor ID
- 2017-07-0043
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Posted 22 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory (24-hour) Blood Pressure | Experimental | Device: Ambulatory (24-hour) Blood Pressure |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged between 30 to 60 years old.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory (24-hour) Blood PressureUnlike 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. | Device | Ambulatory (24-hour) Blood Pressure |
Primary outcome
Change From Baseline in Flow Mediated Dilation After 24 Hour Ischemic Conditioning With Blood Pressure Cuff
Time frame: Baseline, Post 24 hour conditioning
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31249371Fico 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory (24-hour) Blood Pressure in people with Blood Pressure, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Flow Mediated Dilation After 24 Hour Ischemic Conditioning With Blood Pressure Cuff (time frame: Baseline, Post 24 hour conditioning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03303404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.