Acute Myocardial InfarctionSWEATHEARTNCT05843006
Sweat Analysis as Prognosticator After Heart Attack
An observational study of Acute Myocardial Infarction, run by Region Örebro County at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Examination and analysis of sweat and blood samples at baseline and at follow up and Examination and analysis of sweat and blood samples at baseline
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 21 Mar 2022to 31 Mar 2023
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited among patients referred to Örebro University Hospital a tertiary teaching hospital and regional acute care hospital.
Who may be able to join
- 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
Who cannot join
- Emergency coronary artery bypass grafting
- On immunosuppression pharmacotherapy
- Pacemaker patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Examination and analysis of sweat and blood samples at baseline and at follow up, Examination and analysis of sweat and blood samples at baseline
- Keywords
- Sweat analysis, Myocardial reperfusion injury, Personalized patient monitoring, Acute myocardial infarction, Upregulated sympathetic nervous system, Inflammation
- Medical subject headings
- Myocardial Reperfusion Injury, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination and analysis of sweat and blood samples at baseline and at follow upDiagnostic 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.
Examination and analysis of sweat and blood samples at baselineDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| STEMI + PCI | 18 subjects referred for coronary angiography/PCI due to ST-segment elevation myocardial infarction (STEMI) Receives: 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) Receives: Diagnostic Test: Examination and analysis of sweat and blood samples at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start21 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Ole Fröbert, MD, PhD, Study chair, Department of Cardiology, Örebro University Hospital and Örebro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843006
- Sponsor's protocol ID
- 274564
- Acronym
- SWEATHEART
- Status last verified
- Mar 2022
- First submitted
- 24 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39955425
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWEAT Analysis for Predicting Patient Outcome After HEART Attack
- ClinicalTrials.gov ID
- NCT05843006
- Acronym / sponsor ID
- SWEATHEART / 274564
- Conditions
- Acute Myocardial Infarction
- Keywords
- Sweat analysis, Myocardial reperfusion injury, Personalized patient monitoring, Acute myocardial infarction, Upregulated sympathetic nervous system, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI + PCI | – | Diagnostic Test: Examination and analysis of sweat and blood samples at baseline and at follow up18 subjects referred for coronary angiography/PCI due to ST-segment elevation myocardial infarction (STEMI) |
| Diagnostic coronary angiography without a resulting intervention (PCI) | – | Diagnostic Test: Examination and analysis of sweat and blood samples at baseline6 subjects undergoing a diagnostic coronary angiography without a resulting intervention (PCI) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited among patients referred to Örebro University Hospital a tertiary teaching hospital and regional acute care hospital.
Key inclusion criteria (6 listed)
- 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
- Subjects undergoing a diagnostic coronary angiography without a resulting intervention (PCI)
- Written informed consent
Key exclusion criteria (3 listed)
- Emergency coronary artery bypass grafting
- On immunosuppression pharmacotherapy
- Pacemaker patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examination and analysis of sweat and blood samples at baseline and at follow upSubjects 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 test | STEMI + PCI |
| Examination and analysis of sweat and blood samples at baselineSweat 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 test | Diagnostic coronary angiography without a resulting intervention (PCI) |
Primary outcome
Inflammation panels in sweat and blood correlated to clinical outcome
Time frame: 6 weeks
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.
1 secondary outcome
Comparing inflammation panels of patients with coronary angiography without any need for an intervention
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 39955425Bjorkenheim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Fröbert, MD, PhD study chair
Department of Cardiology, Örebro University Hospital and Örebro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation panels in sweat and blood correlated to clinical outcome (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023; AzTrials last refreshed its copy on 29 Oct 2026.