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As we know that in CV department, most of the cardiologists are interventional cardiologist and the experts in AHF are limited, apart from this, the experiences in AHF trial are also limited. It is very difficult to find an ideal investigator.
Our protocol has strict inclusion and exclusion criteria, there are only approx. 15% patients with AHF will fulfill the protocol requirement, What’s more, the diagnosis of AHF based in part on investigators’ judgement, this increase the enrollment difficulty.
When a patient experiences with AHF, most of them present at the ER room, however, the flow of the patients has high variability within hospitals, and also in some sites, and the cooperation between ER and CV department is poor. This makes it hard for the site selection.
And the huge challenge comes from the recruitment challenge in an extremely short timeline- 600 hundred patients in less than a year.
In spite of these challenge, we have already embarked on the journey, this slide showed the potential sites for trial distribution in china.
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