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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02577835
Registration number
NCT02577835
Ethics application status
Date submitted
13/10/2015
Date registered
16/10/2015
Date last updated
1/03/2024
Titles & IDs
Public title
International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
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Scientific title
International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
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Secondary ID [1]
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VASOTENS REGISTRY
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Universal Trial Number (UTN)
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Trial acronym
VASOTENS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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Condition category
Condition code
Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Ambulatory blood pressure monitoring
Hypertensive patients - No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations.
Treatment: Devices: Ambulatory blood pressure monitoring
Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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24-hour Pulse Wave Velocity (PWV)
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Assessment method [1]
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24-hour average value for arterial stiffness was assessed through estimation of the time traveled by the pulse wave from the central arterial tree (aorta) to the peripheral arteries (brachial artery) and measured in meters per sec. The faster the wave travels through the arterial tree, the stiffer the artery is.
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Timepoint [1]
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2 years
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Primary outcome [2]
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24-hour Augmentation Index (AI)
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Assessment method [2]
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24-hour average value for waves reflection expressed as a percentage. The augmentation index is a measure of wave reflection and arterial stiffness and is commonly measured as the ratio of the central pulse pressure and the reflected pulse pressure which augments the central blood pressure. When arteries are stiff, a reflected wave is formed where arteries split. This reflected wave moves back at the heart and increases the pressure at which the heart has to pump. The higher the index the stiffer the artery is.
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Timepoint [2]
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2 years
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Primary outcome [3]
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24-hour Central Blood Pressure
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Assessment method [3]
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24-hour average central aortic pressure expressed in mmHg, as the estimated blood pressure at the level of the thoracic aorta
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Timepoint [3]
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2 years
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Secondary outcome [1]
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24-hour Systolic Blood Pressure
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Assessment method [1]
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Average 24-hour brachial systolic blood pressure (mmHg), namely the systolic blood pressure measured at the level of the brachial artery (upper arm).
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Timepoint [1]
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2 years
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Secondary outcome [2]
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24-hour Diastolic Blood Pressure
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Assessment method [2]
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Average 24-hour brachial diastolic blood pressure (mmHg), namely the diastolic blood pressure measured at the level of the brachial artery (upper arm).
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Cardiac Damage (Left Ventricular Hypertrophy at Echocardiogram or ECG)
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Assessment method [3]
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Left ventricular mass indexed by body surface area (g/m^2) is used to identify left ventricular hypertrophy in case it is increased above a certain threshold (see protocol).
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Vascular Damage (Carotid Plaque at Ultrasonography)
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Assessment method [4]
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Intima media tickness (mm) measured by carotid ultrasonography is used to identify wall thickening or atherosclerotic plaque, when it is above a certain threshold (see protocol).
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Renal Damage (Urine Protein)
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Assessment method [5]
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Urine proteine (mg/24h). The increase above a certain threshold of urine protein is a sign of renal damage (see protocol).
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Timepoint [5]
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2 years
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Eligibility
Key inclusion criteria
- Subjects referred to routine diagnostic evaluation for hypertension or established
hypertensive subject
- ABPM performed for clinical reasons with a BPLab device
- Valid ambualtory blood pressure recordings (interval between measurements not >30
minutes, at least 70% of expected number of readings, at least 20 valid readings
during the day-time and 7 during the night-time)
- Availability of individual measurements for ambulatory blood pressure monitoring
- Availability of basic demographic and clinical information
- Availability of a signed informed consent form
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Age <18 years
- 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
- Pregnancy
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2022
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Sample size
Target
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Accrual to date
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Final
2000
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Macquarie University - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
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Argentina
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Buenos Aires
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Armenia
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Erevan
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Italy
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Brescia
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Italy
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Palermo
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Kazakhstan
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Astana
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Mexico
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State/province [6]
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Guadalajara
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Portugal
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State/province [7]
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Coimbra
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Romania
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Târgu-Mures
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Russian Federation
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State/province [9]
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Chelyabinsk
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Russian Federation
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Chita
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Country [13]
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Russian Federation
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State/province [13]
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Petrozavodsk
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Russian Federation
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State/province [14]
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Rostov-at-Don
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Country [15]
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Russian Federation
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State/province [15]
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St. Petersburg
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Russian Federation
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State/province [16]
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Volgograd
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Country [17]
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Ukraine
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State/province [17]
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Kyiv
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Funding & Sponsors
Primary sponsor type
Other
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Name
Italian Institute of Telemedicine
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Address
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Other collaborator category [1]
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Other
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Name [1]
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BPLab
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This Registry is an investigator-initiated, international, multicenter, observational,
prospective study aiming at: i) evaluating non-invasive 24-h ambulatory blood pressure and
arterial stiffness estimates (through 24-h pulse wave analysis) in hypertensive subjects; ii)
assessing the changes in estimates following treatment; iii) weighing the impact of 24-h
pulse wave analysis on target organ damage and cardiovascular prognosis; iv) assessing the
relationship between arterial stiffness, blood pressure absolute level and variability, and
prognosis. Approximately 2000 subjects, referred to 20 hypertension clinics for routine
diagnostic evaluation and follow-up of hypertension, will be recruited. Data collection will
include ambulatory blood pressure monitoring, performed with a device allowing simultaneous
non-invasive assessment of blood pressure and arterial stiffness, and clinical data
(including cardiovascular outcomes). A web-based telemedicine platform will be used for data
collection. Subjects will visit the centers at 6-12 month intervals. First follow-up results
are expected to be available in the next 2-years. The results of the Registry will help
defining the normalcy thresholds for current and future indices derived from 24-h pulse wave
velocity, according to outcome data. They will also provide supporting evidence for the
inclusion of such evaluation in recommendations on hypertension management.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02577835
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Trial related presentations / publications
Omboni S, Posokhov IN, Parati G, Avolio A, Rogoza AN, Kotovskaya YV, Mule G, Muiesan ML, Orlova IA, Grigoricheva EA, Cardona Munoz E, Zelveian PH, Pereira T, Peixoto Maldonado JM. Vascular Health Assessment of The Hypertensive Patients (VASOTENS) Registry: Study Protocol of an International, Web-Based Telemonitoring Registry for Ambulatory Blood Pressure and Arterial Stiffness. JMIR Res Protoc. 2016 Jun 29;5(2):e137. doi: 10.2196/resprot.5619.
Omboni S, Posokhov IN, Kotovskaya YV, Protogerou AD, Blacher J. Twenty-Four-Hour Ambulatory Pulse Wave Analysis in Hypertension Management: Current Evidence and Perspectives. Curr Hypertens Rep. 2016 Oct;18(10):72. doi: 10.1007/s11906-016-0681-2.
Omboni S, Campolo L, Panzeri E. Telehealth in chronic disease management and the role of the Internet-of-Medical-Things: the Tholomeus(R) experience. Expert Rev Med Devices. 2020 Jul;17(7):659-670. doi: 10.1080/17434440.2020.1782734. Epub 2020 Jun 30.
Omboni S, Panzeri E, Campolo L. E-Health in Hypertension Management: an Insight into the Current and Future Role of Blood Pressure Telemonitoring. Curr Hypertens Rep. 2020 Jun 6;22(6):42. doi: 10.1007/s11906-020-01056-y.
Omboni S, Arystan A, Benczur B. Ambulatory monitoring of central arterial pressure, wave reflections, and arterial stiffness in patients at cardiovascular risk. J Hum Hypertens. 2022 Apr;36(4):352-363. doi: 10.1038/s41371-021-00606-4. Epub 2021 Sep 13.
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Public notes
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Contacts
Principal investigator
Name
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Stefano Omboni, MD
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Address
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Italian Institute of Telemedicine
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Fax
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Email
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Contact person for public queries
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02577835
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