Healthy Volunteers Clinical Trial
— ULTRAFASTECHOOfficial title:
Establishment of Local Arterial Stiffness Normal Values (Carotid and Femoral) on Healthy Volunteers Using Supersonic Shear Imaging
Verified date | March 2015 |
Source | French Cardiology Society |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
Arterial stiffness is associated with increased risk of cardiovascular events and death.
Most of existing technique need dedicated device for arterial stiffness evaluation and
indirect calculation of intra arterial pressure. Supersonic Shear Imaging (SSI) is a novel
non-invasive technique based on remote palpation of biological tissues that can image with
very high temporal resolution (up to 10,000 images/s) and quantify the local viscoelastic
properties of tissues. The investigators goal was to apply this SSI technique for arterial
stiffness evaluation and local pulse wave velocity (PWV) calculation.
As a first step, the primary goal of this study is to establish normal values of local pulse
wave velocity and arterial stiffness (carotid and femoral) by SSI on hundred healthy
volunteers.
Status | Completed |
Enrollment | 145 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion criteria for Healthy Volunteers - Healthy volunteers between 18 and 70 years old of two sexes. - Caucasian origin - No tobacco or stopped for more than 5 years - BMI between 18 and 30 kg/m2. - Blood pressure after 5 minutes of rest < 140 and 90 mmHg. - Biological test (haematological biochemistry test in blood , urine test and toxicology tests are all normal) ECG, Blood pressure and Heart rhythm normal. - All volunteers received information on the research and signed the consent form. - Health system protection required Inclusion criteria for patient : - Age between, 18 et 70 years old for the two sexes - Presence of two major criteria of Villefranche classification (Am J Med Genet 1998 ;77:31-7) and/or heterozygote pathogen mutation of COL3A1 gene. - At least 4cm long normal arterial segment (carotid or femoral) analyzed by mode B echograph. - All patient received information on the research and signed the consent form. - Health system protection required General Exclusion Criteria : - Pregnancy - Echograph gel allergy - Local Artery disease (dissection or thrombosis) - Arrhythmia - No health insurance coverage - Incapacity or refused to sign the consent form Exclusion criteria for Healthy volunteers - Acute or Chronic Systemic disease (atherosclerosis) - Alcohol abuse or drug abuse (cocaine,cannabis,etc..) - Active or past tobacco - Hypercholesterolemia (LDLc >1.09 g/l) - Exclusion period according to the national record for volunteer of clinical trial. Exclusion criteria for Patients - No intact (carotid or femoral) segment for SSI analysis - AT2 inhibitors or Beta blockers treatment will be notified but are not considered as exclusion criteria. |
Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | CIC - Hôpital Européen Georges Pompidou | Paris |
Lead Sponsor | Collaborator |
---|---|
French Cardiology Society | National Research Agency, France, SOCIETE FRANCAISE DE MEDECINE VASCULAIRE |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normal Values by SSI | Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral). | day one | No |
Secondary | repeatability of the "primary outcome measure" | Evaluation of the repeatability of the "primary outcome measure" on 100 healthy volunteers and 30 patients with Vascular Ehlers Danlos Syndrome (vEDS). | Day one | No |
Secondary | Comparison between 2 populations of values by SSI | Comparison between healthy volunteers and vEDS patients for PWV and arterial stiffness evaluated by SSI. | Day one | No |
Secondary | Comparison of values between SSI and standard gold | Concordance evaluation between PWV calculated by SSI and Aortic Pulse wave velocity calculated by ShygmoCor® | Day one | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |