Trial Outcomes & Findings for Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management (NCT NCT03015363)

Results Overview

Central aortic pressure (mmHg)

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.

Results posted on

2021-08-30

Participant Flow

A total of 37 eligible patients voluntarily consented to participate in the study, although 3 participants withdrew and 14 participants failed to meet the study eligibility criteria.

Participant milestones

Participant milestones
Measure	Prospective Cohort (1) Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Overall Study STARTED	37
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Prospective Cohort (1) Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Overall Study Physician Decision	14
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prospective Cohort (1) n=20 Participants Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Age, Continuous	62.0 years STANDARD_DEVIATION 9.0 • n=20 Participants
Sex: Female, Male Female	5 Participants n=20 Participants
Sex: Female, Male Male	15 Participants n=20 Participants
Region of Enrollment Canada	20 participants n=20 Participants
Smoking (%)	3 Participants n=20 Participants
Diabetes (%)	7 Participants n=20 Participants
Dyslipidemia (%)	14 Participants n=20 Participants
Hypertension (%)	15 Participants n=20 Participants

PRIMARY outcome

Timeframe: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.

Population: Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.

Central aortic pressure (mmHg)

Outcome measures

Outcome measures
Measure	Prospective Cohort (1) n=20 Participants Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Systolic Pressure	133.4 mmHg Standard Deviation 22.0

PRIMARY outcome

Timeframe: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.

Population: Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.

Central aortic pressure (mm Hg)

Outcome measures

Outcome measures
Measure	Prospective Cohort (1) n=20 Participants Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Diastolic Pressure	67.4 mmHg Standard Deviation 8.7

PRIMARY outcome

Timeframe: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.

Population: Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.

Peripheral arterial pressure (mm Hg)

Outcome measures

Outcome measures
Measure	Prospective Cohort (1) n=20 Participants Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Systolic Pressure	145.7 mmHg Standard Deviation 20.2

PRIMARY outcome

Timeframe: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.

Population: Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.

Peripheral arterial pressure (mm Hg)

Outcome measures

Outcome measures
Measure	Prospective Cohort (1) n=20 Participants Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.
Diastolic Pressure	66.2 mmHg Standard Deviation 9.1

Adverse Events

Prospective Cohort (1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sohrab Lutchmedial, MD, FRCP(C)

CardioVascular Research New Brunswick (CVR-NB)

Phone: 506-648-6101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place