Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05843006
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-04-24
Brief Title:
Sweat Analysis as Prognosticator After Heart Attack
Sponsor:
Region Örebro County
Organization:
Region Örebro County
Study Overview
Official Title:
SWEAT Analysis for Predicting Patient Outcome After HEART Attack
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWEATHEART
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by norepinephrine secretion Further STEMI has been associated with increased sweating during the acute phase In an unpublished pilot trial we detected a broad panel of inflammation markers in sweat such as MCP-1 TGFβ uPa TRAIL of healthy volunteers Sweat immunologic marker analysis is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 STEMIPCI - 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 STEMIPCI
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 STEMIPCI - 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 STEMIPCI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None