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

January 30, 2014
February 1, 2014
December 2013
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02053623 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Hypertension
  • Atrial Fibrillation
  • Obesity
  • Heart Failure
  • Atherosclerosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
Not Provided
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT02053623
HPI-219939
No
Health Parametrics Inc.
Health Parametrics Inc.
Not Provided
Not Provided
Health Parametrics Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP