Coronary Artery DiseaseECSNCT06084091
Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
An observational study of Coronary Artery Disease and Heart Valve Diseases, run by Spectrocor at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Heart Valve Diseases
- What is being tested?
- Myocardial spectrometric measurement
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 6 Oct 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for open-heart operation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Heart and Lung Center
Helsinki, Uusimaa, 00029
Peter Raivio, MD, PhD, +358 50 4272283, peter.raivio@hus.fi
Tatu Juvonen, Professor, +358 50 4080562, tatu.juvonen@hus.fi
About this study
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
Read the 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 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.
- Conditions
- Coronary Artery Disease, Heart Valve Diseases
- Being tested
- Myocardial spectrometric measurement
- Keywords
- monitoring, intraoperative, Heart Surgery
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial spectrometric measurementDevice
Myocardial spectrometric measurement during open-heart Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial spectrometric recording
Can the device record myocardial spectrometric data during open-heart surgery
Measured: During operation
Measurement correlation
How the measurements correlate with the occurring events, procedures, and clinical parameters during the operation.
Measured: During operation
Secondary outcomes (1)
Adverse event assessment
Assessment of the adverse events of the device.
Measured: From admission to discharge, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start6 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spectrocor
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Raivio, PhD, Principal investigator, Chief of Department, Head and Lung Center, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084091
- Sponsor's protocol ID
- Safe-op 1.0 ECS
- Acronym
- ECS
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
- ClinicalTrials.gov ID
- NCT06084091
- Acronym / sponsor ID
- ECS / Safe-op 1.0 ECS
- Conditions
- Coronary Artery Disease, Heart Valve Diseases
- Keywords
- monitoring, intraoperative, Heart Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SpectrocorIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for open-heart operation
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myocardial spectrometric measurementMyocardial spectrometric measurement during open-heart Surgery | Device | – |
Primary outcome
Myocardial spectrometric recording
Time frame: During operation
Can the device record myocardial spectrometric data during open-heart surgery
Measurement correlation
Time frame: During operation
How the measurements correlate with the occurring events, procedures, and clinical parameters during the operation.
1 secondary outcome
Adverse event assessment
Time frame: From admission to discharge, up to 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Raivio, PhD principal investigator
Chief of Department, Head and Lung Center, Hospital District of Helsinki and Uusimaa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Heart Valve Diseases, run by Spectrocor at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Raivio, PhD (+358 50 4272283, peter.raivio@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial spectrometric recording (time frame: During operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.