VALIDATION OF AUTOMATIC DEVICES IN THE CLINIC: VALIDAC-1

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

VALIDAC-1

Scientific title:

Validation study for the clinical use of the Hipermax BF automatic blood pressure measurement device in the general population.

Acronym of Scientific Title:

VALIDAC HIPERMAX-BF

Secondary indentifying numbers:

VALIDAC-1

Issuing authority of the secondary identifying numbers:

COMBIOMED Digital Medical Technology

Source(s) of monetary or material support:

Ministry of Public Health (MINSAP) , Institute of Cardiology and Cardiovascular Surgery (ICCCV) , COMBI0MED Digital Medical Technology

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

28/02/2022

Reference number:

05.001.21Q

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Damaris

Last name:

Hernandez Veliz

Medical Specialty :

First Degree Specialist in Cardiology

Affiliation:

Institute of Cardiology and Cardiovascular Surgery (ICCCV)

Postal address:

17 Street No. 702 between A and Paseo, Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78382653

+53-78307250

Email address:

dhveliz@infomed.sld.cu [1]

damiveliz73@gmail.com [2]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

03/03/2022

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Arterial hypertension

Health condition(s) code:

Hypertension

Vascular Diseases

Cardiovascular Diseases

Intervention(s):

Participants enrolled in the study will have their blood pressure measured eigth times with both the auscultatory method as the gold standard for the reference measurement and the oscillometer with the sphygmomanometer to be validated (Hipermax FB device). This process will be carried out 8 times to complete the three pairs of valid measurements established by the standard. The estimated duration for each patient is 1 hour.

Intervention code:

Sphygmomanometers

Blood Pressure Monitoring, Ambulatory

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Blood pressure value measured with the HIPERMAX BF (equipment under test) and the Mercury Column (reference equipment). Measurement time: A maximum of eight pairs of readings will be taken per subject, with intervals of 1 min. The evaluation criteria will be the relationship between the measurement of the HIPERMAX BF with that carried out by two certified experts using the reference device.

Key secondary outcomes:

Not applicable

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

12 years

Maximum age:

None

Inclusion criteria:

1. In all cases, informed consent will be obtained. 2. Age 12 years or older, not pregnant 3. No arrhythmias (Electrocardiogram) 4. Blood pressure in the SBP 80-220 mmHg and DBP 50-120 mmHg ranges (Initial blood pressure measurement)

Exclusion criteria:

1. Refusal to be part of the study. 2. Belonging to a group classified as a special population: children under 12 years of age or pregnant women. 3. K5 Korotkoff sound not audible in one subject. 4. Cardiac arrhythmias

Type of population:

Children and Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Observational

Purpose:

Diagnostic

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yamile

Last Name:

Valdes Gonzalez

Specialty:

First Degree Specialist in Internal Medicine

Affiliation:

University Hospital "General Calixto Garcia"

Postal Address:

Avenida Universidad and J. Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-53307438

Email :

yamile.valdes@infomed.sld.cu [3]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Damaris

Last Name:

Hernandez Veliz

Specialty:

First Degree Specialist in Cardiology

Affiliation:

Institute of Cardiology and Cardiovascular Surgery (ICCCV)

Postal Address:

17 Street No. 702 between A and Paseo, Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78307250, +53-78382653

Email :

dhveliz@infomed.sld.cu [1]

damiveliz73@gmail.com [4]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Institute of Cardiology and Cardiovascular Surgery

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

14/05/2021

Postal address of Ethic Committee :

17 Street No. 702 b/ A and Paseo, Vedado, Havana Cuba ZC 10400

Telephone:

+53-78386272

Email:

dircardio@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

24/03/2022

Date of available results:

15/03/2023

Date of first publication:

27/10/2023

Results Study

Section to complete the data related to the summarized results.

Results file:

RPCEC00000400-Results-En.pdf [5]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000400

Date of Registration in Primary Registry:

04/02/2022

Record Verification Date:

2024/02/09

Next update date:

2025/02/09

Link to the spanish version:

Click here [6]