Sweat Analysis as Prognosticator After Heart Attack

NCT ID: NCT05843006

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2023-03-31

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 In an unpublished pilot trial, we detected a broad panel of inflammation markers in sweat (such as MCP-1, TGFβ, uPa, TRAIL) of healthy volunteers.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.

Conditions

Acute Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

STEMI + PCI

18 subjects referred for coronary angiography/PCI due to ST-segment elevation myocardial infarction (STEMI)

Examination and analysis of sweat and blood samples at baseline and at follow up

Intervention Type: DIAGNOSTIC_TEST

Subjects will be assessed at baseline (as inpatients) and at 4-6 weeks at follow-up as outpatients according to standard operating procedures. Sweat samples will be collected using the CE certified Macroduct Sweat Collector and inflammatory parameters measured. Venous blood will be drawn and inflammatory parameters, Troponin-I and nt-proBNP measured. Further examinations include measurement of left ventricular ejection fraction by echocardiography at baseline and blood pressure, heart rate, risk scores and health information will be collected at baseline and follow up.

Diagnostic coronary angiography without a resulting intervention (PCI)

6 subjects undergoing a diagnostic coronary angiography without a resulting intervention (PCI)

Examination and analysis of sweat and blood samples at baseline

Intervention Type: DIAGNOSTIC_TEST

Sweat samples will be collected using the CE certified Macroduct Sweat Collector and inflammatory parameters measured. Venous blood will be drawn and inflammatory parameters, Troponin-I and nt-proBNP measured. Blood pressure, heart rate, risk scores and health information will collected.

Interventions

Examination and analysis of sweat and blood samples at baseline and at follow up

Subjects will be assessed at baseline (as inpatients) and at 4-6 weeks at follow-up as outpatients according to standard operating procedures. Sweat samples will be collected using the CE certified Macroduct Sweat Collector and inflammatory parameters measured. Venous blood will be drawn and inflammatory parameters, Troponin-I and nt-proBNP measured. Further examinations include measurement of left ventricular ejection fraction by echocardiography at baseline and blood pressure, heart rate, risk scores and health information will be collected at baseline and follow up.

Intervention Type: DIAGNOSTIC_TEST

Examination and analysis of sweat and blood samples at baseline

Sweat samples will be collected using the CE certified Macroduct Sweat Collector and inflammatory parameters measured. Venous blood will be drawn and inflammatory parameters, Troponin-I and nt-proBNP measured. Blood pressure, heart rate, risk scores and health information will collected.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ole Fröbert, MD, PhD

Role: STUDY_CHAIR

Department of Cardiology, Örebro University Hospital and Örebro University

Locations

Department of cardiology

Örebro, , Sweden

Countries

Sweden

References

Bjorkenheim A, Sunnefeldt E, Finke K, Smith DR, Frobert O, Brasier N. Biomarkers of inflammation in sweat after myocardial infarction. Sci Rep. 2025 Feb 15;15(1):5564. doi: 10.1038/s41598-025-90240-8.

Reference Type: DERIVED

PMID: 39955425 (View on PubMed)

Other Identifiers

274564

Identifier Type: -

Identifier Source: org_study_id