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Completed

NCT Number: NCT04205032

Evaluation in Healthy Volunteers of CARDIOSPACE II

The aim of this project is to test the CARDIOSPACE II system that integrates several medical devices. This system is dedicated to physiological studies in space environment.

* Electrocardiogram * Vascular doppler * Laser doppler with iontophoresis * Continuous blood pressure recording at the finger level * Brachial blood pressure * Ultrasound * Ambulatory Electrocardiogram and SAO2 (arterial oxygen saturation) recorder

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Angers, Clinical Research Center

Angers, Maine Et Loire, 49000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Height between 160 et 180 cm
  • Body mass index between 18 et 24
  • Normal blood pressure, heart rate and cardio-pulmonary auscultation at rest
  • Normal electrocardiogram
  • Possibility to perform transcranial doppler
  • Able to understand aims and constraints of this study
  • National health insurance
  • Signature of the informed consent form

Exclusion criteria

  • Pregnant woman (Beta HCG - human chorionic gonadotropin - with urinary test) or breastfeeding
  • Participating at the time to another clinical trial investigating
  • Reached or surpassed the annual amount of financial compensation allowed by clinical trials (according to French regulation)
  • Taking any chronic treatment
  • Any sign of cardiovascular or respiration disease
  • Any sign of syncopal events by questioning (>2 events per year)
  • Contraindication to perform physical activity

Treatment and study plan

Test of the different devices integrated in cardiospace II

Device

The different devices included in CARDIOSPACE II will be tested

  • Electrocardiogram
  • Vascular Doppler
  • LaserDoppler and iontophoresis
  • Brachial blood pressure
  • Continuous blood pressure recorded at the finger level
  • Ultrasound
  • Ambulatory Electrocardiogram / SAO2 (arterial oxygen saturation)

Primary outcomes

  1. Quality of the ECG signal given by CARDIOSPACE II: scale

    Time frame: Through study completion, an average of 6 months

    ECG signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise

  2. Quality of the vascular Doppler signal: scale

    Time frame: Through study completion, an average of 6 months

    Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise

  3. Quality of the laser doppler signal: scale

    Time frame: Through study completion, an average of 6 months

    Laser Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise

  4. Quality of the ultrasound images: scale

    Time frame: Through study completion, an average of 6 months

    Ultrasound images will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable image and 5 is a very clear image

  5. Quality of the blood pressure wave: scale

    Time frame: Through study completion, an average of 6 months

    Blood pressure wave signal will be estimated by by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise

  6. Quality of the ambulatory measurements (ECG / SAO2)

    Time frame: Through study completion, an average of 6 months

    ECG and SaO2 ambulatory measurements will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Astronautic Center of China (ACC)
  • Centre National des Etudes Spatiales - French Space Agency (CNES)

Registry information

Official study title

Evaluation in Healthy Volunteers of CARDIOSPACE II for Physiological Studies in Space

Acronym: CDSII

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2019
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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