Status:
UNKNOWN
Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
Lead Sponsor:
Spectrocor
Conditions:
Coronary Artery Disease
Heart Valve Diseases
Eligibility:
All Genders
18-90 years
Brief Summary
The goal of this observational study is to test in the safety and performance of intraoperative myocardial spectroscopic measurement in open-heart surgery patients The main questions it aims to answe...
Detailed Description
The study design is based on measuring the depth of ischemia during the operation, which is compared to the intraoperative and postoperative morbidity of the patient, especially to the dysfunction of ...
Eligibility Criteria
Inclusion
- Any 18 to 90-year-old patient scheduled for an open-heart operation
- The ability to understand the study's objective and the risks involved.
- Informed consent obtained, including the agreement to authorization to use the protected personal patient records according to privacy legislation.
Exclusion
- Inability to obtain an informed consent form
- Patients included as vulnerable population according to Finnish Medical Research Act, including retarded, pregnant women, nursing mothers, prisoners, or forensic patients.
Key Trial Info
Start Date :
October 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06084091
Start Date
October 6 2023
End Date
November 30 2025
Last Update
October 25 2023
Active Locations (1)
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1
Heart and Lung Center
Helsinki, Uusimaa, Finland, 00029