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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Health Parametrics Inc.
ClinicalTrials.gov Identifier:
NCT02053623
First received: January 30, 2014
Last updated: February 1, 2014
Last verified: January 2014
  Purpose

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
Hypertension
Atrial Fibrillation
Obesity
Heart Failure
Atherosclerosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Health Parametrics Inc.:

Primary Outcome Measures:
  • Accurate and Consistent Blood Pressure Measurement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: December 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02053623

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

No publications provided

Responsible Party: Health Parametrics Inc.
ClinicalTrials.gov Identifier: NCT02053623     History of Changes
Other Study ID Numbers: HPI-219939
Study First Received: January 30, 2014
Last Updated: February 1, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 16, 2014