NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs062180013

Registered date:28/12/2018

Volume Elastic Modulus as an Atherosclerotic Marker (Volume Elastic Modulus)

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedCardiovascular risk factors (hypertension, dyslipidemia, or diabetes mellitus) or cardiovascular dis
Date of first enrollment01/10/2018
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Measurements of TM-2772, FMD, and NID

Outcome(s)

Primary OutcomeAssociations of Volume Elastic Modulus measured by Health Chronos TM2772 with flow-mediated vasodilation (FMD), and nitroglycerine-induced vasodilation (NID)
Secondary Outcome1. Associations of Volume Elastic Modulus measured by Health Chronos TM2772 with cardiovascular risk parameters and ankle-brachial index 2. Associations between brachial artery cross-sectional area measured by Health Chronos TM2772 and brachial artery cross-sectional area measured by ultrasound 3. Safety evaluation

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patients with hypertension, dyslipidemia, diabetes mellitus, smoking, or cardiovascular disease 2. Patients with age of 20 years old or more
Exclude criteria1. Unhealed wound in upper arm, stasis dermatitis, or shunt 2. Hypotension, cardiogenic shock 3. Angle-closure glaucoma 4. Head injury, intracranial hemorrhage 5. Severe anemia 6. Hypersensitivity to nitrate 7. Receiving treatment with phosphodiesterase 5 inhibitors or guanylate cyclase activators 8. Pregnant female 9. Judgement of an attending physician that an individual is ineligible for inclusion in the study

Related Information

Contact

Public contact
Name Tatsuya Maruhashi
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5831
E-mail 55maruchin@gmail.com
Affiliation Research Institute for Radiation Biology and Medicine, Hiroshima University
Scientific contact
Name Yukihito Higashi
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5831
E-mail yhigashi@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital