CARDIOSPACE Evaluation in Healthy Volunteers

University Hospital, Angers

Status: Completed

Conditions: Healthy

Treatments: Device: CARDIOSPACE System

Study type: Interventional

Funder types: Other

Identifiers

NCT02704247

CHU-P 2014-01

Details and patient eligibility

About

The aim of this porject is to test the Cardiospace system that integrates several medical devices to monitor the cardiovascular system:

• ECG
• Brachial blood pressure
• Continuous finger blood pressure
• Ultrasound
• Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the cardiovascular system of astronauts for research purpuse.

Enrollment: 2 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age : 18 to 40 years

• Size : 160 à 180

• Weight : BMI between 18 and 24

• Medical history :

  • No history of cardiovascular disease
  • No chronic treatment
  • No syncopal events (>2 by year)

• Physical examination

  • Normal cardio-pulmonary ausculation
  • Normal (DBP [60 - 90] SBP [100 - 140]
  • Normal heart rate (between 50 and 80 at rest)

• Complementary examination

  • Normal Electrocardiogram
  • Presence of temporal acoustic window

• Capable to understand the objectives and constraints of this study

• Covered by health social insurance

• Have signed the informed consent

Exclusion criteria

• Pregnant woman (beta HCG by urinary test) or breastfeeding

  • Refusing to sign the informed consent
  • Don't understand the objectives of this study
  • Minors or majors protect by the law
  • Don't Benefit of social insurance
  • Participation at the time of study enrolment during the present trial period in another clinical trial investigating.
  • Having reached or surpassed the annual amount of compensation allowed by clinical trials
  • Receipt of any chronic and regular treatment
  • Presence of sign cardiovascular diseases during the questioning
  • Presence of sign cardiovascular diseases during the examination
  • Presence of sign syncopals events ATCD diseases during the questioning (>2 by year)
  • Absence of temporal acoustic window with the Transcranial Doppler
  • Respiratory disorder, asthma
  • Any troubles preventing the realization of physical activity

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Testing CARDIOSPACE System

Experimental group

Description:

Healthy volunteers have to test CARDIOSPACE System

Treatment:

Device: CARDIOSPACE System