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Trial record 2 of 6392 for:    zero

Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03732924
Recruitment Status : Not yet recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
KMH Cardiology and Diagnostic Centres
Information provided by (Responsible Party):
Sheldon Tobe, Sunnybrook Health Sciences Centre

Brief Summary:
The Hypertension Canada Clinical Practice Guidelines for blood pressure measurement using AOBP recommend against any wait time prior to commencing the measurement. The recent AHA guidelines however call for a 5-minute rest first. In uncontrolled hypertension, AOBP is typically higher than the daytime readings from ambulatory blood pressure monitoring (ABPM), but this is not the case for patients with controlled hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Diseases Diagnostic Test: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement Not Applicable

Detailed Description:

Objective:

Does a 5 minute rest or no rest before measurement using AOBP provide the most accurate reading in patients with controlled and uncontrolled hypertension, and in patients with white coat hypertension compared to daytime ABPM?

Implications:

Through this study, we hope to:

(i) Advance the understanding of the role of AOBP in measuring blood pressure. (ii) Determine whether a 5-minute rest, or no rest at all is needed prior to AOBP measurement.

(iii) Assess the relationship of AOBP to daytime ABPM for patient with controlled and uncontrolled hypertension and in patients with white coat hypertension.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement: the Impact of a 5 Minute Rest Time on AOBP Measurement
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Five Diagnostic Test: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement
To compare the difference between the daytime ABPM and AOBP with zero or five minutes wait time.

No Intervention: Zero



Primary Outcome Measures :
  1. Difference in systolic and diastolic BP in patients randomized to zero or five minutes wait before the AOBP measurement. [ Time Frame: 4 months - 1 yr ]

Secondary Outcome Measures :
  1. Difference in systolic and diastolic BP between the AOBP and daytime ABPM in patients randomized to zero or five minutes wait before the AOBP measurement. [ Time Frame: 4 months - 1yr ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

" Age 18 years or older " Referred for ABPM " Written informed consent

Exclusion Criteria:

  • Unable to perform AOBP or ABPM for some reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732924


Contacts
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Contact: Diane Hua-Stewart, MPH 4167103892 diane.hua@sunnybrook.ca
Contact: Sheldon Tobe, MD 416-480-4755 sheldon.tobe@sunnybrook.ca

Sponsors and Collaborators
Sunnybrook Health Sciences Centre
KMH Cardiology and Diagnostic Centres

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Responsible Party: Sheldon Tobe, Primary Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03732924     History of Changes
Other Study ID Numbers: 181-2018
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases