Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05843006 |
| Other study ID # |
274564 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 21, 2022 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
March 2022 |
| Source |
Region Örebro County |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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unpublished pilot trial, we detected a broad panel of inflammation markers in sweat (such as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.
