臨床研究等提出・公開システム

Performance validation study of the Frailty Finder in elderly patients with heart failure

FF01-01 Study

Nagai Toshiyuki

Hokkaido University Hospital

Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido

nagai@med.hokudai.ac.jp

Nagai Toshiyuki

Hokkaido University Hospital

Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido

+81-11-716-1161

nagai@med.hokudai.ac.jp

Complete

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

Patients meeting all of the following criteria will be selected:
1. Patients diagnosed with chronic heart failure based on the diagnostic criteria outlined in the Japanese Circulation Society's Guidelines for the Management of Acute and Chronic Heart Failure.
2. Patients aged 75 years or older at the time of consent.
3. Patients who have received a thorough explanation of this clinical trial and provided written informed consent.

Subjects meeting any of the following criteria will be excluded from this clinical trial:
1. Patients unable to walk according to instructions.
2. Patients deemed unsuitable for the clinical trial at the discretion of the physician.

Both

Elderly patients with chronic heart failure

Two videos of walking along a designated course are recorded, and the Clinical Frailty Scale (CFS) is analyzed based on the obtained image data.

Evaluation of error between the Clinical Frailty Scale (CFS) calculated by investigational devices and labeling results by Japanese Circulation Society board-certified cardiologists (assessed by QWK)

1. Evaluation of error in CFS calculated by investigational medical devices and labeling results by Japanese Circulation Society board-certified cardiologists (assessed by QWK).
2. Agreement rate for each CFS between CFS calculated by investigational medical devices and labeling results by Japanese Circulation Society board-certified cardiologists.
3. Agreement rate for each CFS between CFS calculated by investigational medical devices at each medical institution and labeling results by Japanese Circulation Society board-certified cardiologists.
4. Frequency of misclassification by two or more grades of CFS calculated by the application compared to labeling results by Japanese Circulation Society board-certified cardiologists.
5. Evaluation of differences in results from repeated tests (multiple tests conducted at the same timing for the same patient).

No

None