Clinical trial NCT05843006: Sweat Analysis as Prognosticator After Heart Attack
Official title: SWEAT Analysis for Predicting Patient Outcome After HEART Attack
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Sweat analysis
Myocardial reperfusion injury
Personalized patient monitoring
Acute myocardial infarction
Upregulated sympathetic nervous system
Inflammation
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2023-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study participants will be recruited among patients referred to Örebro University Hospital a tertiary teaching hospital and regional acute care hospital.

Brief summary: This study characterizes non-invasive body inflammation response in sweat and blood of patients suffering from acute myocardial infarction and explores the potential of non-invasive sweat analysis a an innovative approach for predicting patient outcome.

Detailed description: Background:

Different risk scores exist for predicting patient outcome after acute coronary syndrome and percutaneous coronary intervention (PCI). This is of importance to optimize post interventional patient management as well as treatment and to reduce the risks of re-hospitalization and mortality. ST-elevation myocardial infarction (STEMI) has been associated with an instant upregulation of the sympathetic nervous system leading to adrenergic stimulation and immune system activation in different organs such as the heart and skin. In skin, sympathetic fibers travel together, appear as single nerve fibers in the dermis as well as in the epidermis, and activate inflammation by norepinephrine secretion. Further, STEMI has been associated with increased sweating during the acute phase. In an unpublished pilot trial, we detected a broad panel of inflammation markers in sweat (such as MCP-1, TGFβ, uPa, TRAIL) of healthy volunteers. Sweat immunologic marker analysis is an interesting and novel approach for assessment of sympathetic activation and inflammation.

Objective and methods:

Our primary objective is to assess a non-invasive body inflammation response in sweat and blood of patients suffering from STEMI after PCI (+4h) and at outpatient follow up (±4-6 weeks). Body inflammation marker concentrations in sweat and blood will be set into context to cardiovascular risk factors, GRACE and TIMI STEMI scores, door-to-balloon time, length of hospital stay , left ventricular ejection fraction, peak troponin-I, and NT-proBNP concentrations to investigate the STEMI/PCI - sympathetic nervous system - inflammation axis. A total of 18 subjects with STEMI and 6 patients undergoing diagnostic coronary angiography without PCI will be recruited in a clinical, single-center pilot study at Örebro University Hospital. Sweat will be collected using the CE certified Macroduct Collecting System and blood samples will be taken. Analysis will be performed with Olink proteomic analysis.

Clinical relevance:

STEMI and subsequent reperfusion are associated with an increase in inflammatory response. Myocardial reperfusion injury contributes significant to myocardial injury after STEMI. Adequate patient monitoring and therapy after PCI is essential to preserve cardiac function, prevent re-hospitalization, heart failure and death.

Prospects:

Biomarkers can be collected by smart biosensors and may provide novel longitudinal insights into health and disease. On-skin sweat analysis using wearable devices are increasingly available and will allow collection of non-invasive and patient-centered molecular health information in the future. This may help to investigate a better understanding of sympathetic nervous system upregulation after STEMI/PCI.

Eligibility criteria: Inclusion Criteria:

Study participants will be recruited among subjects referred to Hospital for coronary angiography/PCI due to ST-segment elevation myocardial infarction (STEMI) or diagnostic coronary angiography.

Subjects with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block

Or:

Subjects undergoing a diagnostic coronary angiography without a resulting intervention (PCI)

and:

Written informed consent

Exclusion Criteria:

* Emergency coronary artery bypass grafting
* On immunosuppression pharmacotherapy
* Pacemaker patients

Primary outcomes:
measure: Inflammation panels in sweat and blood correlated to clinical outcome
timeFrame: 6 weeks
Secondary outcomes:
measure: Comparing inflammation panels of patients with coronary angiography without any need for an intervention
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of cardiology
Study officials:
affiliation: Department of Cardiology, Örebro University Hospital and Örebro University
name: Ole Fröbert, MD, PhD
role: STUDY_CHAIR
References: