protocolSection identificationModule nctId: NCT06294730, orgStudyIdInfo id: 2018/1891-31, briefTitle: COronary Microcirculation and Troponin Elevation in Septic Shock, acronym: COMTESS, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-06-13, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: Plasma cardiac troponin (cTn) elevation is an indicator of increased mortality in patients with sepsis yet the underlying cause of troponin elevation in sepsis is not known. The COMTESS study investigates whether elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in hemodynamically unstable patients with sepsis can be explained by an underlying coronary artery disease or a process within the coronary microcirculation. Fifty patients with sepsis and with hs-cTnT elevation (\>15 ng/L) will undergo coronary angiography, including an assessment of coronary flow using a method called thermo-dilution to record the index of microcirculatory resistance (IMR) in the left anterior descending artery (LAD). The relationship between IMR and hs-cTnT will subsequently be analysed. It is important to identify the underlying causes of elevated cTn during sepsis to target further research with an aim to improve the survival in patients suffering from this condition., conditionsModule conditions: Sepsis, conditions: Myocardial Injury, conditions: Coronary Microvascular Dysfunction, conditions: Endothelial Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Relationship between hs-cTnT and IMR, secondaryOutcomes measure: Relationship between hs-cTnT and CFR, secondaryOutcomes measure: Relationship between hs-cTnT and BRI, secondaryOutcomes measure: Relationship between hs-cTnT and number of diseased epicardial coronary vessels, secondaryOutcomes measure: Relationship between hs-cTnT and Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX)-score, secondaryOutcomes measure: Relationship between hs-cTnT and left ventricular end diastolic pressure (LVEDP), secondaryOutcomes measure: Relationship between hs-cTnT and Tricuspid annular plane systolic excursion (TAPSE), secondaryOutcomes measure: Relationship between hs-cTnT and echocardiographic measurements of left ventricular global strain, secondaryOutcomes measure: Relationship between hs-cTnT and echocardiographic measurements of left diastolic dysfunction, secondaryOutcomes measure: Relationship between measures of endothelial dysfunction and IMR, secondaryOutcomes measure: Relationship between measures NETs and IMR, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, Danderyd University Hospital, status: RECRUITING, city: Stockholm, zip: 182 88, country: Sweden, contacts name: Jonas Persson, MD, PhD, role: CONTACT, phone: +46 70-089 1412, email: jonas.persson@regionstockholm.se, contacts name: Samantha Lörstad, MD, role: CONTACT, phone: +46708693973, email: samantha.rutherford-lorstad@regionstockholm.se, contacts name: Jonas Persson, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Samantha Lörstad, MD, role: SUB_INVESTIGATOR, contacts name: Tomas Jernberg, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Sara Tehrani, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Per Åstrand, MD, role: SUB_INVESTIGATOR, contacts name: Christina Ekenbäck, MD, role: SUB_INVESTIGATOR, contacts name: Fadi Jokhaji, MD, role: SUB_INVESTIGATOR, contacts name: Kambiz Shahgaldi, PhD, role: SUB_INVESTIGATOR, contacts name: Charlotte Thålin, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Patrik Gille-Johnson, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False