Cooperative development of hemodynamic monitor including cardiac output based on the measurement of lung-finger circulation time.

JRCT ID: jRCTs072180003

Registered date:03/09/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: ex.1) heart failure (including pre-heart failure subjects) ex.2) healthy subjects
• Date of first enrollment: 11/09/2018
• Target sample size: 15
• Study type: Interventional
• Intervention(s): MRI, Fx sensor

Outcome(s)

Primary Outcome

ex.1) % error value in Bland-Altman analysis to quantify agreement between MRI Q-Flow and new device method.
ex.2) % error value in Bland-Altman analysis to quantify agreement of MRI Q-Flow measurement in two facilities

• Secondary Outcome: None

Key inclusion & exclusion criteria

• Age minimum: 20 years old
• Age maximum: None
• Gender: Both

Include criteria

ex.1) Admitted or out-patients at Fukuokaken Saiseikai Hospital or normal volunteers
ex.2) Normal volunteers

Exclude criteria

ex.1)
1. Acute phase of coronary heart disease (<7 days).
2. Uncontrolled hypertension (office blood pressure over 180/110mmHg).
3. Uncontrolled heart failure patients (needing oxygen inhalation).
4. Patients who cannot keep supine position.
5. Patients who cannot obey the instruction of breath-holding.
6. Patients with claustrophobia.
7. Patients with permanent pacemaker.
8. Patients with peripheral arterial disease.
9. Patients with arterial obstruction between heart and finger
10. Patients under hemodialysis.
11. Patients with the history of lung disease such as COPD or asthma.
12. Patients with intra- or extra-cardiac arterial-venous shunt.

ex.2)
1. Subjects with heart disease.
2. Subjects with pulmonary disease.
3. Subjects who cannot keep supine position.
4. Subjects who cannot obey the instruction of breath-holding.
5. Subjects with claustrophobia.
6. Subjects with permanent pacemaker.

Related Information

• Primary Sponsor: Ando Shin-ichi
• Secondary Sponsor: Japan Agency for Medical Research and Development
• Source(s) of Monetary Support: Fuji Xerox CO., Ltd.