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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02053623
• Other study ID #: HPI-219939
• Status: Terminated
• Phase: N/A
• First received: January 30, 2014
• Last updated: February 22, 2017
• Start date: April 2, 2015
• Est. completion date: July 2, 2015

Study information

• Verified date: February 2017
• Source: Health Parametrics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 2, 2015
• Est. primary completion date: May 21, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Atrial Fibrillation
• Heart Failure
• Hypertension
• Obesity

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Health Parametrics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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