Sweat Analysis as Prognosticator After Heart Attack (SWEATHEART)

SWEAT Analysis for Predicting Patient Outcome After HEART Attack

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.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Diagnostic test: Examination and analysis of sweat and blood samples at baseline and at follow up; Diagnostic test: Examination and analysis of sweat and blood samples at baseline

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 In an unpublished pilot trial, we detected a broad panel of inflammation markers in sweat (such as MCP-1, TGFβ, uPa, TRAIL) of healthy volunteers.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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70185
    • Department of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STEMI + PCI; 18 subjects referred for coronary angiography/PCI due to ST-segment elevation myocardial infarction (STEMI)	Diagnostic test: 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.
Diagnostic coronary angiography without a resulting intervention (PCI); 6 subjects undergoing a diagnostic coronary angiography without a resulting intervention (PCI)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation panels in sweat and blood correlated to clinical outcome	The primary result is detection of inflammation markers in sweat and blood samples in patients with STEMI and PCI. Inflammation markers will be correlated to clinical outcome. Clinical endpoints will be assessed in all patients included in the study using data from the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry - death, new AMI and new, unplanned revascularization. Assessment is exploratory only.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing inflammation panels of patients with coronary angiography without any need for an intervention	Secondary results are detection of inflammation markers in sweat and blood of patients with coronary angiography but no need for intervention and compared to patients with STEMI and PCI. Clinical endpoints will be assessed as described for the primary outcome measure.	6 weeks

Collaborators and Investigators

• Sponsor: Region Örebro County
• Collaborators: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Ole Fröbert, MD, PhD, Department of Cardiology, Örebro University Hospital and Örebro University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Myocardial reperfusion injury; Acute myocardial infarction; Sweat analysis; Personalized patient monitoring; Upregulated sympathetic nervous system
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 274564

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No