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Evaluation of a Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor

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ClinicalTrials.gov Identifier: NCT02053623
Recruitment Status : Terminated (Technical issues & lack of funds)
First Posted : February 3, 2014
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Health Parametrics Inc.

Brief Summary:

Approximately one billion people suffer from hypertension worldwide. At least 10% of this population, that is, 100 million people, also suffers from associated chronic conditions namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF). Personal interaction with medical practitioners (doctors) and review of published clinical research confirms that current non-invasive automatic blood pressure (BP) monitors that rely on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP estimation can lead to wrong diagnoses and hence to complications such as stokes and heart attacks.

The Sponsor is developing a novel non-invasive BP monitor that is similar to existing automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in conjunction with BP pulse data to provide better and more accurate measurements in the above chronic conditions.

The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP monitor against invasive BP measurements in a small group of patients who suffer from the above conditions.


Condition or disease
Hypertension Atrial Fibrillation Obesity Heart Failure Atherosclerosis

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of a Novel Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor Against Invasive Intra-Arterial Pressure Monitoring - A Pilot Study
Actual Study Start Date : April 2, 2015
Actual Primary Completion Date : May 21, 2015
Actual Study Completion Date : July 2, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Accurate and Consistent Blood Pressure Measurement [ Time Frame: 12 months ]
    We expect to demonstrate that our automated non-invasive ECG-assisted BP monitoring technology can provide accurate and consistent diastolic & systolic pressure measurements in chronic patient conditions (namely AF, obesity, AS, and HF) in which current non-invasive oscillometric technologies tend to be unreliable.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will recruit a minimum of 20 qualified adult patients who come to the catheterization lab at the University of Ottawa Heart Institute for an angiography. The patients will have at least one of the following chronic conditions: atrial fibrillation, obesity, atherosclerosis, and heart failure.
Criteria

Inclusion:

  1. Patients undergoing an angiography in the catheterization lab who also suffer from at least one of the following chronic conditions:

    • Established diagnosis of AF.
    • Obesity characterized by a BMI > 40 (extremely high, Class III).
    • Established diagnosis of AS.
    • Established diagnosis of HF.
  2. Age ≥ 18 years.

Exclusion:

  1. Patients unwilling or unable to comply with study requirements.
  2. Failure to sign the informed consent form.
  3. Age < 18 years.

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): NCT02053623


Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Health Parametrics Inc.

Responsible Party: Health Parametrics Inc.
ClinicalTrials.gov Identifier: NCT02053623     History of Changes
Other Study ID Numbers: HPI-219939
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases