Myocardial IschemiaNCT07785141
Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
An observational study of Myocardial Ischemia and Heart Defects, Congenital, run by Spectrocor at 1 site in Finland.
Trial summary
The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric patients during open-heart surgery. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Myocardial Ischemia, Heart Defects, Congenital, Reperfusion Injury, Myocardial
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 17 Sep 2026to 28 Feb 2029
- Phase
- Observational
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patient scheduled for an open-heart operation.
Who may be able to join
- Scheduled for open-heart surgery.
- Age <18
- Signed informed consent
Who cannot join
- Inability to provide informed consent
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
HUS New Childrens Hospital
Helsinki, Uusimaa, 00290
Tommi Pätilä, PhD, tommi@spectrocor.com
Kalle Kotilahti, PhD, kalle@spectrocor.com
About this study
The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric patients during open-heart surgery.
Patients of less than 18 years old who, and whose guardian(s), when applicable according to national legislation, have signed the informed consent, can participate in the study.
Read more
The primary hypothesis is that the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor can detect myocardial oxygen availability in pediatric open-heart surgery patients. It is expected that the detected tissue oxygenation timely correlates with procedures affecting myocardial perfusion and other clinical parameters during the operation.
The secondary hypothesis is that the SpectroCor Tissue Oxygenation Monitor and its accessory, the SpectroCor Sensor, are safe to use, and their usability is acceptable.
No comparison group is included in the study.
The devices are used by the study investigators during open-heart surgery to collect myocardial tissue spectrometer data from the pediatric population to validate and potentially further develop the monitor and its accessory, the sterile sensor. The follow-up period for each participant ends with discharge from the hospital. No data (such as questionnaires) are obtained directly from the study participants.
Read the detailed description
This is a single-center study. Thirty participants, less than 18 years old, with planned elective open-heart surgery, will be recruited for this study. The primary purpose is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor peripheral tissue oxygenation perioperatively. This open, non-controlled observational study aims to assess the monitor's ability, in combination with the sensor, to monitor and observe tissue oxygenation and the safety of the device in routine clinical practice, reflecting the real-world patient population and treatment scenarios. Therefore, no control group is needed.
For this clinical investigation, pediatric age groups will be defined according to the ICH E11/EMA framework (neonates: 0-28 days; infants: 1-23 months; children: 2-11 years; adolescents: 12-17 years). Although these definitions originate from medicinal product regulation, they are widely accepted and provide a consistent basis for pediatric clinical research.
There is currently no separate international classification system specific to medical devices. However, the ICH E11/EMA framework is appropriate for device investigations because it reflects physiological differences in growth and development that are directly relevant to cardiac surgery and to the intended uses of the monitor and sensor. In particular, the greatest physiological differences compared to adults are found in neonates and infants, where cardiac size, myocardial composition, and perioperative risks differ substantially.
The study, therefore, aims to include patients across the pediatric spectrum with emphasis on neonates and infants, while allowing flexibility in recruitment numbers. Data from older children and adolescents can be reasonably bridged to adult data, given similarities in cardiac anatomy and physiology. This approach ensures that safety and usability are adequately assessed across the relevant pediatric subpopulations without imposing rigid subgroup quotas, which would be impractical in this rare and heterogeneous patient population.
Primary endpoint:
The ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability.
Secondary endpoints:
Incidence of (serious) adverse events, (serious) adverse device effects, and device deficiencies.
- Medical subject headings
- Myocardial Ischemia, Heart Defects, Congenital, Myocardial Reperfusion Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to observe/monitor changes in myocardial oxygen availability
Proportion of monitor-sensor applications demonstrating expected myocardial oxygenation response - percentage of applications in which the device detects a decrease in Hb/Mb saturation and CcOx oxidation after aortic cross-clamping, an increase after de-clamping, and/or an increase after blood cardioplegia administration.
Measured: Intraoperatively, from sensor insertion to removal; typically 1 to 6 hours.
Secondary outcomes (4)
Incidence of device or protocol-related adverse events
An Adverse Event (AE) is an untoward medical occurrence, unintended disease or injury, or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users, or other persons, in the context of a clinical investigation, whether related to the investigated device. This definition includes events that are anticipated as well as unanticipated events occurring in a clinical investigation related to the investigated device or the procedures involved.
Measured: From informed consent through hospital discharge; assessed up to approximately 30 days
Incidence of device or protocol-related adverse device events and serious adverse device events
An Adverse Device Effect (ADE) is any AE related to the use of an investigational medical device.
This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device, and any event resulting from use error or from intentional misuse of the investigational medical device.
A Serious Adverse Device Effect (SADE) is an ADE that has resulted in any of the consequences characteristic of a serious adverse event. SAEs related to procedures imposed by the clinical investigation plan but not with the use of the device shall not be considered Serious Adverse Device Effects.
Measured: From informed consent through hospital discharge; assessed up to approximately 30 days
Incidence of device or protocol-related serious adverse events
A Serious Adverse Event (SAE) is any AE that led to any of the following:
- death; b) serious deterioration in the health of the subject that resulted in any of the following: (i) life-threatening illness or injury; (ii) permanent impairment of a body structure or a body function; (iii) hospitalization or prolongation of patient hospitalization; (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function; (v) chronic disease.
Measured: From informed consent through hospital discharge; assessed up to approximately 30 days
Incidence of device defeciencies
A Device Deficiency (DD) is any inadequacy in the identity, quality, durability, reliability, safety, or performance of an investigational device, including malfunction, use errors, or inadequacy in information supplied by the manufacturer.
Measured: From informed consent through hospital discharge; assessed up to approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start17 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spectrocor
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital District of Helsinki and Uusimaa
- Responsible party
- Sponsor
- Investigators
- Henri Haapanen, PhD, Principal investigator, Helsinki University Hospital (HUS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785141
- Sponsor's protocol ID
- Ped Plegia
- Other IDs
- FIMEA/2025/004527
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The investigation enrols minors undergoing congenital cardiac surgery at a single centre, a rare and heterogeneous population in which the small sample size and detailed intraoperative and perioperative data create a substantive risk of re-identification. Participant consent and the approved Clinical Investigation Plan do not cover secondary sharing of individual-level data, and the sponsor's obligations under Regulation (EU) 2016/679 (GDPR) preclude onward transfer without a valid legal basis. Aggregate results will be published in accordance with the publication policy and made publicly available in EUDAMED, and the clinical investigation report will be submitted to the competent authority within one year of the end of the investigation.
Publications
Bridgewater B; Adult Cardiac Surgeons of North West England. Mortality data in adult cardiac surgery for named surgeons: retrospective examination of prospectively collected data on coronary artery surgery and aortic valve replacement. BMJ. 2005 Mar 5;330(7490):506-10. doi: 10.1136/bmj.330.7490.506.
PubMed 15746131Patila T, Kukkonen S, Vento A, Pettila V, Suojaranta-Ylinen R. Relation of the Sequential Organ Failure Assessment score to morbidity and mortality after cardiac surgery. Ann Thorac Surg. 2006 Dec;82(6):2072-8. doi: 10.1016/j.athoracsur.2006.06.025.
PubMed 17126112Chen JC, Kaul P, Levy JH, Haverich A, Menasche P, Smith PK, Carrier M, Verrier ED, Van de Werf F, Burge R, Finnegan P, Mark DB, Shernan SK; PRIMO-CABG Investigators. Myocardial infarction following coronary artery bypass graft surgery increases healthcare resource utilization. Crit Care Med. 2007 May;35(5):1296-301. doi: 10.1097/01.CCM.0000262403.08546.A2.
PubMed 17414091Lomivorotov VV, Efremov SM, Pokushalov EA, Romanov AB, Ponomarev DN, Cherniavsky AM, Shilova AN, Karaskov AM, Lomivorotov VN. Randomized trial of fish oil infusion to prevent atrial fibrillation after cardiac surgery: data from an implantable continuous cardiac monitor. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1278-84. doi: 10.1053/j.jvca.2014.02.019. Epub 2014 Jul 11.
PubMed 25027101Maganti M, Badiwala M, Sheikh A, Scully H, Feindel C, David TE, Rao V. Predictors of low cardiac output syndrome after isolated mitral valve surgery. J Thorac Cardiovasc Surg. 2010 Oct;140(4):790-6. doi: 10.1016/j.jtcvs.2009.11.022. Epub 2010 Feb 11.
PubMed 20152992Flogel U, Fago A, Rassaf T. Keeping the heart in balance: the functional interactions of myoglobin with nitrogen oxides. J Exp Biol. 2010 Aug 15;213(Pt 16):2726-33. doi: 10.1242/jeb.041681.
PubMed 20675541Shiva S, Sack MN, Greer JJ, Duranski M, Ringwood LA, Burwell L, Wang X, MacArthur PH, Shoja A, Raghavachari N, Calvert JW, Brookes PS, Lefer DJ, Gladwin MT. Nitrite augments tolerance to ischemia/reperfusion injury via the modulation of mitochondrial electron transfer. J Exp Med. 2007 Sep 3;204(9):2089-102. doi: 10.1084/jem.20070198. Epub 2007 Aug 6.
PubMed 17682069Brookes PS, Levonen AL, Shiva S, Sarti P, Darley-Usmar VM. Mitochondria: regulators of signal transduction by reactive oxygen and nitrogen species. Free Radic Biol Med. 2002 Sep 15;33(6):755-64. doi: 10.1016/s0891-5849(02)00901-2.
PubMed 12208364Lindbergh T, Larsson M, Szabo Z, Casimir-Ahn H, Stromberg T. Intramyocardial oxygen transport by quantitative diffuse reflectance spectroscopy in calves. J Biomed Opt. 2010 Mar-Apr;15(2):027009. doi: 10.1117/1.3374050.
PubMed 20459283Cohen GA, Permut LC, Arakaki LS, Ciesielski WA, McMullan DM, Parrish AR, Schenkman KA. Direct optical measurement of intraoperative myocardial oxygenation during congenital heart surgery. ASAIO J. 2011 Jul-Aug;57(4):314-7. doi: 10.1097/MAT.0b013e3182179881.
PubMed 21508828Ohira S, Tanaka H, Harada Y, Minamikawa T, Kumamoto Y, Matoba S, Yaku H, Takamatsu T. Label-free detection of myocardial ischaemia in the perfused rat heart by spontaneous Raman spectroscopy. Sci Rep. 2017 Feb 10;7:42401. doi: 10.1038/srep42401.
PubMed 28186163Lelovas PP, Kostomitsopoulos NG, Xanthos TT. A comparative anatomic and physiologic overview of the porcine heart. J Am Assoc Lab Anim Sci. 2014 Sep;53(5):432-8.
PubMed 25255064Drury NE. Myocardial protection in paediatric cardiac surgery: building an evidence-based strategy. Ann R Coll Surg Engl. 2024 Mar;106(3):277-282. doi: 10.1308/rcsann.2023.0004. Epub 2023 May 30.
PubMed 37249560Turkoz R. Myocardial protection in pediatric cardiac surgery. Artif Organs. 2013 Jan;37(1):16-20. doi: 10.1111/aor.12029.
PubMed 23305570Jobsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. doi: 10.1126/science.929199.
PubMed 929199