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

Evaluation of a Novel Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor Against Invasive Intra-Arterial Pressure Monitoring - A Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Hypertension; Obesity; Atherosclerosis; Atrial Fibrillation

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accurate and Consistent Blood Pressure Measurement	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.	12 months

Collaborators and Investigators

• Sponsor: Health Parametrics Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2015
• Primary Completion (ACTUAL): May 21, 2015
• Study Completion (ACTUAL): July 2, 2015

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: February 1, 2014
• First Posted (ESTIMATE): February 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atherosclerosis
• Other Study ID Numbers: HPI-219939