The objectives of the project are:
- To create a worldwide network of centers performing ambulatory blood pressure monitoring (ABPM) recordings (including specialized Hypertension Centers and General Practitioners)
- To collect a large registry of subjects from different countries in whom basic clinical information is available as well as at least one ABPM fulfilling the predefined criteria
- To design and conduct a series of research studies focusing on ABPM and based on this collected dataset
- To promote the application of ABPM in clinical practice and to disseminate knowledge on its correct use and interpretation
- To actively collaborate with international scientific societies in their activities related to ABPM, in particular in the preparation of recommendations for ABPM use in clinical and research setting
This is an international, multicenter, observational, project.
The registry includes:
- Prevalent Data: subjects fulfilling the inclusion criteria whose data are contained in existing
databases collected by the participating centers
- Incident Data: the participating centers include in the
database consecutive subjects undergoing ABPM
The minimum required average recruitment rate is 100 subjects per Hypertension center and 30 subjects per year for a General Practitioner.
- Male and female subjects
- Age ≥18 years
- ABPM performed for clinical reasons or within another research project
- ABPM performed with a validated device, fulfilling the following validity criteria in the prevalent
database: interval between measurements not exceeding 30 minutes,
at least 70% of expected number of readings were obtained,
at least 40 readings were obtained over 24 hours
- ABPM performed with a validated device, fulfilling the following validity criteria in the incident
database: interval between measurements not exceeding 20 minutes during daytime (3 readings per hour) and 30 minutes during night-time (2 readings per hour)
- in case of Microlife WatchBP 03 devices provided to the investigators this interval should be of 15 minutes throughout 24 hours,
recording duration of at least 24 hours, at least 70% of expected number of readings were obtained, there are not more than two hours in the recording without valid readings, there are no consecutive hours without valid readings
- Availability of raw ABPM data (individual measurements) as data files (excluding image files, pdf reports etc.)
- Availability of basic clinical information:
age, sex, BMI, smoking status, dyslipidemia, diabetes,
diagnosis of hypertension, current antihypertensive
treatment status, clinic blood pressure obtained in the same treatment condition as ABPM
- Availability of a signed informed consent form
- Atrial fibrillation, frequent ectopic beats, second or third degree atrioventricular blocks, or other conditions which might make difficult or unreliable the automatic blood pressure measurement with the oscillometric technique
- Upper arm circumference <22 cm
Prevalent Data Registry: existing electronic
databases of subjects fulfilling the inclusion criteria
are directly transferred to project Data Management with a clear description of variables. These data
are transformed as needed and included in the main
Incident Data Registry: every subject is submitted to a 24h ambulatory blood pressure recording using validated devices and in accordance with the procedures described in the Appendix I. Hypertension Clinics make use of the validated devices already available in their unit while General Practitioners
may be provided with a Microlife WatchBP 03 device.
Data collection is ensured by a dedicated web-based multilingual telemedicine system (in all countries except Spain where another web-based system is already in use for the ongoing project). When using the Microlife device, a web-based software
is used to program the device and to download data at the end of the recording. Data
are transmitted to the project website and analyzed in real-time with production of an electronic report sent by e-mail to the Investigator and available on the website. Ambulatory blood pressure data collected with validated blood pressure monitors other than the WatchBP 03 may be included in the system by uploading the file directly on the website.
The web-based telemedicine system also includes a dedicated e-CRF, allowing collection of patient’s clinical data, such as family history, anthropometric data, habits, past and current diseases, therapies, office BP, and possibly laboratory tests, including evaluation of target organ damage. The e-CRF
also allows uploading attachments with raw ultrasound data (report of cardiac and carotid examinations) and digital ECG. The same system estimates the patient’s cardiovascular risk level according to ESC-ESH risk table.
A subsample of subjects also simultaneously performs home blood pressure monitoring by using a Microlife WatchBP Home through the same telemedicine system. Also in this case files of home blood pressure recordings performed by other validated devices
can possibly be uploaded on the website.
More than one ABPM recordings may be performed in the same patient if deemed necessary by the physician in charge. They
are uploaded in the telemedicine system and complemented by an update of clinical information, in particular with regard to office blood pressure and treatment. The project does not involve any type of intervention and the physicians manage the patients included in the registry according to the requirements of clinical practice. They
are also free to use the ambulatory blood pressure data in the clinical management of the patients.
The telemedicine system allows a) standardized and centralized data collection, b) data validation, c) setup of a network between experts (Specialists) and General Practitioners aiming at supporting doctors’ interpretation of ambulatory tracings and consequent medical decision.
Standard variables derived from raw ABPM data are calculated immediately once the data are input in the
database and their adequate quality is verified. These includes hourly means, 24h, daytime and night.time averages and standard deviations.
Other variables of interest will be defined in the framework of studies based on the ARTEMIS registry and calculated subsequently according to the procedures defined separately in each study protocol.
Basic descriptive statistics of the entire registry are calculated and reported on the project website at regular intervals, to be defined.
Statistical procedures of studies based on the ARTEMIS registry will be defined separately in each study protocol.