Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery

Coronary Artery Disease Clinical Trial

— ECS  

Official title:

Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084091
• Other study ID #: Safe-op 1.0 ECS
• Status: Recruiting
• Start date: October 6, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: October 2023
• Source: Spectrocor
• Contact: Peter Raivio, PhD
• Phone: +358 50 4272283
• Email: peter.raivio[@]hus.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 answer are:

• The Devices can record myocardial spectrometric data for analysis, and

• How these measures correlate with the occurring events, procedures, and clinical parameters during the operation.

• Number of participants with device-related adverse events as assessed by CTCAE v4.0

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 the heart. A qualified and experienced Monitor is assigned for the study to oversee and document the progress of the trial. The Monitor ensures the trial performance in accordance with the Protocol and Good Clinical Practice (GCP). The trial team conforms to ISO 13485 quality standards and ISO 14155 GCP. Processes included in the monitoring activities are documented in the quality management system. Below are described the summaries of all these activities. Source data will be collected and transferred into the electronic CRFs by site staff, and the collected data quality and the conformity to the Good Clinical Practice will be assessed by monitoring. Based on a risk assessment performed, a Data Monitoring Committee shall not be established. Clinical Research Associate (CRA) is responsible for checking the accuracy and completeness of Case Report Form (CRF) entries, source documents, and other investigation-related records against each other. Other responsibilities of CRA, including detailed Source Data Verification (SDV), are documented by the clinical project manager (CPM) or head of clinical research (HCR)(both are sponsor's representatives). SDVs will be performed and documented during monitoring visits. Monitoring planning, reporting, and visits are pre-defined and documented with pre-made templates per the sponsor's quality management system. Monitoring visits will be performed to cover data from all study participants, and according to QMS and the Standard Operation Procedures. The monitoring shall ensure that all source documentation is precise and document control is exercised in all relevant documentation. The monitoring ensures, that the Adverse events are always reported and appropriate authorities or stakeholders are informed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Valve Diseases

Intervention

Device:
• Myocardial spectrometric measurement
Myocardial spectrometric measurement during open-heart Surgery

Locations

Country	Name	City	State
Finland	Heart and Lung Center	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Spectrocor

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial spectrometric recording	Can the device record myocardial spectrometric data during open-heart surgery	During operation
Primary	Measurement correlation	How the measurements correlate with the occurring events, procedures, and clinical parameters during the operation.	During operation
Secondary	Adverse event assessment	Assessment of the adverse events of the device.	From admission to discharge, up to 2 weeks