Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT05843006
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 In an unpublished pilot trial, we detected a broad panel of inflammation markers in sweat (such as MCP-1, TGFβ, uPa, TRAIL) of healthy volunteers.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.
Study:
NCT05843006
Study Brief:
Protocol Section:
NCT05843006