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

JRCT ID: jRCTs062180013

Registered date:28/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cardiovascular risk factors (hypertension, dyslipidemia, or diabetes mellitus) or cardiovascular dis
• Date of first enrollment: 01/10/2018
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Measurements of TM-2772, FMD, and NID

Outcome(s)

• Primary Outcome: Associations of Volume Elastic Modulus measured by Health Chronos TM2772 with flow-mediated vasodilation (FMD), and nitroglycerine-induced vasodilation (NID)

Secondary Outcome

1. 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 maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with hypertension, dyslipidemia, diabetes mellitus, smoking, or cardiovascular disease
2. Patients with age of 20 years old or more

Exclude criteria

1. 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

• Primary Sponsor: Higashi Yukihito
• Source(s) of Monetary Support: A&D Company, Limited