Ang-1 study by various age groups

JRCT ID: jRCT1050230011

Registered date:11/04/2023

Basic Information

• Recruitment status: Not Recruiting

Health condition(s) or Problem(s) studied

Healthy persons
Problem studied: Vasculopathy in Systemic Sclerosis.

• Date of first enrollment: 14/11/2023
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Participants warm their upper arms near the elbow wearing the holder with the disposable warmer inserted for 7 days.

Outcome(s)

• Primary Outcome: Distribution of Angiopoietin-1 in fingertip blood samples by age groups
• Secondary Outcome: Changes in Angiopoietin-1 in fingertip blood samp blood samples before and after warming the upper arm with the disposable warmer.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) persons who are 20 years old or elder and younger than 80 years old,
2) persons who understand the instruction and description video of the self blood collection kit (DEMECAL) in Japanese,
3) persons who live in Japan,
4) persons who have given written informed consent of their own free will.

Exclude criteria

1) persons who take medications that cause bleeding tendency,
2) persons with diabetes mellitus or who have been diagnosed with diabetes mellitus,
3) persons with collagen disease or a history of collagen disease,
4) Persons who are intolerable to alcohol disinfectants,
5) Persons who are physically, temporarily, or geographically unable to post and return the self-blood collection kit,
6) Persons who are deemed inappropriate by the principal investigator.

Related Information

• Primary Sponsor: Shima Yoshihito
• Source(s) of Monetary Support: Kobayashi Pharmaceutical Co., Ltd.