Clinical trial: CARDIOSPACE Evaluation in Healthy Volunteers (NCT02704247)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? Contradiction