Sweat Analysis as Prognosticator After Heart Attack

NCT05843006 | Completed

• 1 other identifier: 274564
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Keywords

Sweat analysis; Myocardial reperfusion injury; Personalized patient monitoring; Acute myocardial infarction; Upregulated sympathetic nervous system; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparing inflammation panels of patients with coronary angiography without any need for an intervention

  6 weeks

Study Arms (2)

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

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

Interventions

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

STEMI + PCI

Examination and analysis of sweat and blood samples at baseline 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.

Diagnostic coronary angiography without a resulting intervention (PCI)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Emergency coronary artery bypass grafting
• On immunosuppression pharmacotherapy
• Pacemaker patients

Sponsors & Collaborators

• Region Örebro County: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

Department of cardiology

Örebro, 70185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39955425 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Sweat and venous blood samples for analysis and storage in a biobank in Örebro for potential future analysis.

MeSH Terms

Conditions

Myocardial Reperfusion Injury; Inflammation

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ole Fröbert, MD, PhD

  Department of Cardiology, Örebro University Hospital and Örebro University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: March 21, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2022-03

Locations

SE (1)