Venous Thromboembolism (VTE)NCT06731673
Heat Shock Protein 47 in Thrombosis
An observational study of Venous Thromboembolism (VTE) and Acute Myocardial Infarction With ST Segment Elevation, run by University of Aarhus at 2 sites in 2 countries.
Trial summary
The goal of this observational study is to learn if the novel biomarker Heat shock protein 47 (HSP47) can be used as a prognostic marker for vascular disease in people with acute venous thromboembolism (VTE), myocardial infarction (AMI) or ischaemic stroke compared to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism (VTE), Acute Myocardial Infarction With ST Segment Elevation, Stroke (in Patients With Atrial Fibrillation)
- How many people
- 340 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Dec 2024to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited at Aarhus University Hospital at the department of Cardiology (AMI, VTE), Neurology (Stroke) and Radiology (VTE) and at the Blood Bank (Healthy volunteers).
Who may be able to join
- 18 years of age or older
- Informed consent
- VTE group:
- Deep vein thrombosis confirmed on ultrasonography OR
- Pulmonary embolism confirmed on computed tomography angiography (CTA)
- AMI group:
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- ST-segment elevation on electrocardiogram (ECG) AND
- Culprit lesion(s) on coronary angiography
- Stroke group:
- Stroke confirmed on magnetic resonance imaging AND
- Atrial fibrillation (Detected on ECG, telemtry or Holter monitoring) AND
- Stroke localisation classic for AFib: cortical, cerebellar, brainstem or subcortical >1.5 cm in diameter
- Healthy group:
- Healthy
Who cannot join
- <18 years of age
- no informed consent
- Known haematological disorders
- Active haematological malignancy
- Severe renal insufficiency defined as eGFR <15 or dialysis
- VTE - Pulmonary embolism incidentally detected by CTA conducted for purposes unrelated to pulmonary embolism assessment without concomitant DVT
Show all 14Show fewer
- AMI
- Coronary dissection
- Takotsubo cardiomyopathy
- Stroke
- Stroke from other causes, e.g. findings pointing towards large vessel disease
- Healthy
- Known acute or chronic disease
- Prior VTE, AMI, stroke or other thromboembolic event
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Central Region, 8200
Kathrine A Friis, PhD-student, +45 20 86 75 94, kathrinefriis@live.dk
Erik L Grove, Assoc. Prof., MD
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum de Charité
Berlin, State of Berlin, 12203
Tobias Petzold, Prof., MD, +49 30- 450- 613745, tobias.petzold@dhzc-charite.de
Tobias Petzold, Prof., MD
About this study
Official title: Heat Shock Protein 47: A Novel Biomarker of Thrombosis Risk
The goal of this observational study is to learn if the novel biomarker Heat shock protein 47 (HSP47) can be used as a prognostic marker for vascular disease in people with acute venous thromboembolism (VTE), myocardial infarction (AMI) or ischaemic stroke compared to healthy volunteers. The main questions it aims to answer are:
- Are platelet levels of HSP47 higher in patients with acute VTE, AMI or stroke, compared to healthy volunteers.
- Does platelet levels of HSP47 remain elevated in patients with acute thrombotic events compared to healthy volunteers at 3 and 12-months of follow-up.
- Are platelet levels of HSP47 postively associated with platelet function and negatively associated with fibrinolytic capacity in patients with an acute thrombotic event.
Participants with VTE, AMI or stroke will be giving a blood sample at diagnosis and again after 3 and 12 months of follow-up. Healthy volunteers will be giving a blood sample once.
- Conditions
- Venous Thromboembolism (VTE), Acute Myocardial Infarction With ST Segment Elevation, Stroke (in Patients With Atrial Fibrillation)
- Keywords
- HSP47, Heat Shock Protein 47, Biomarker, Novel biomarker, Trombosis, VTE, AMI, Stroke
- Medical subject headings
- Venous Thromboembolism, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Venous thromboembolism | Patients with acute deep vein thrombosis diagnosed on UL or pulmonary embolism diagnosed on CTA. >18 years of age. 120 patients in total. | |
| Acute myocardial infarction | With ST segment elevation on ECG and confirmed culprit lesion on coronary angiography. >18 years of age. 50 patients in total. | |
| Stroke | Stroke confirmed on MRI and diagnosis of atrial fibrillation. >18 years of age. 50 patients in total. | |
| Healthy participants | No known or prior diseases, no medication. >18 years of age. 120 in total. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet levels of heat shock protein 47 (HSP47) in patients with thrombosis compared to healthy controls
The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry.
Measured: From enrollment to end of follow-up at 12 months after enrollment. At 3 time points.
Secondary outcomes (3)
Changes in platelet levels of HSP47 over time in patients with thrombosis
The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry.
Measured: From enrollment to 12 months of follow-up. Measured at 3 time points.
Platelet levels of HSP47 in association to platelet function
The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry. Platelet function will be assessed by platelet aggregation and activation using impedance aggregometry and flow cytometry.
Measured: From enrollment to 12 months of follow-up. Measured at 3 time points.
Platelet levels of HSP47 in association to fibrinolytic capacity
The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry. Fibrinolytic capacity will be assessed by ROTEM (R) tPA methods established in our lab, and by plasma fibrinolysis analyses.
Measured: From enrollment to 12 months of follow-up. Measured at 3 time points.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start9 Dec 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
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 Venous Thromboembolism (VTE)Studies 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
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Max Planck Institute of Biochemistry, Deutsches Herzzentrum der Charité, Berlin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731673
- Sponsor's protocol ID
- HSP47
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thienel M, Muller-Reif JB, Zhang Z, Ehreiser V, Huth J, Shchurovska K, Kilani B, Schweizer L, Geyer PE, Zwiebel M, Novotny J, Lusebrink E, Little G, Orban M, Nicolai L, El Nemr S, Titova A, Spannagl M, Kindberg J, Evans AL, Mach O, Vogel M, Tiedt S, Ormanns S, Kessler B, Dueck A, Friebe A, Jorgensen PG, Majzoub-Altweck M, Blutke A, Polzin A, Stark K, Kaab S, Maier D, Gibbins JM, Limper U, Frobert O, Mann M, Massberg S, Petzold T. Immobility-associated thromboprotection is conserved across mammalian species from bear to human. Science. 2023 Apr 14;380(6641):178-187. doi: 10.1126/science.abo5044. Epub 2023 Apr 13.
PubMed 37053338
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Shock Protein 47: A Novel Biomarker of Thrombosis Risk
- ClinicalTrials.gov ID
- NCT06731673
- Acronym / sponsor ID
- HSP47
- Conditions
- Venous Thromboembolism (VTE), Acute Myocardial Infarction With ST Segment Elevation, Stroke (in Patients With Atrial Fibrillation)
- Keywords
- HSP47, Heat Shock Protein 47, Biomarker, Novel biomarker, Trombosis, VTE, AMI, Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Max Planck Institute of Biochemistry, Deutsches Herzzentrum der Charité, Berlin
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Dec 2024 (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.
The goal of this observational study is to learn if the novel biomarker Heat shock protein 47 (HSP47) can be used as a prognostic marker for vascular disease in people with acute venous thromboembolism (VTE), myocardial infarction (AMI) or ischaemic stroke compared to healthy volunteers. The main questions it aims to answer are:
- Are platelet levels of HSP47 higher in patients with acute VTE, AMI or stroke, compared to healthy volunteers.
- Does platelet levels of HSP47 remain elevated in patients with acute thrombotic events compared to healthy volunteers at 3 and 12-months of follow-up.
- Are platelet levels of HSP47 postively associated with platelet function and negatively associated with fibrinolytic capacity in patients with an acute thrombotic event.
Participants with VTE, AMI or stroke will be giving a blood sample at diagnosis and again after 3 and 12 months of follow-up. Healthy volunteers will be giving a blood sample once.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Venous thromboembolism | – | –Patients with acute deep vein thrombosis diagnosed on UL or pulmonary embolism diagnosed on CTA. >18 years of age. 120 patients in total. |
| Acute myocardial infarction | – | –With ST segment elevation on ECG and confirmed culprit lesion on coronary angiography. >18 years of age. 50 patients in total. |
| Stroke | – | –Stroke confirmed on MRI and diagnosis of atrial fibrillation. >18 years of age. 50 patients in total. |
| Healthy participants | – | –No known or prior diseases, no medication. >18 years of age. 120 in total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited at Aarhus University Hospital at the department of Cardiology (AMI, VTE), Neurology (Stroke) and Radiology (VTE) and at the Blood Bank (Healthy volunteers).
Key inclusion criteria (14 listed)
- 18 years of age or older
- Informed consent
- Deep vein thrombosis confirmed on ultrasonography OR
- Pulmonary embolism confirmed on computed tomography angiography (CTA)
- ST-segment elevation on electrocardiogram (ECG) AND
Key exclusion criteria (14 listed)
- <18 years of age
- no informed consent
- Known haematological disorders
- Active haematological malignancy
- Severe renal insufficiency defined as eGFR <15 or dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet levels of heat shock protein 47 (HSP47) in patients with thrombosis compared to healthy controls
Time frame: From enrollment to end of follow-up at 12 months after enrollment. At 3 time points.
The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry.
3 secondary outcomes
Changes in platelet levels of HSP47 over time in patients with thrombosis
Time frame: From enrollment to 12 months of follow-up. Measured at 3 time points.
Platelet levels of HSP47 in association to platelet function
Time frame: From enrollment to 12 months of follow-up. Measured at 3 time points.
Platelet levels of HSP47 in association to fibrinolytic capacity
Time frame: From enrollment to 12 months of follow-up. Measured at 3 time points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Background: PubMed 37053338Thienel M, Muller-Reif JB, Zhang Z, Ehreiser V, Huth J, Shchurovska K, Kilani B, Schweizer L, Geyer PE, Zwiebel M, Novotny J, Lusebrink E, Little G, Orban M, Nicolai L, El Nemr S, Titova A, Spannagl M, Kindberg J, Evans AL, Mach O, Vogel M, Tiedt S, Ormanns S, Kessler B, Dueck A, Friebe A, Jorgensen PG, Majzoub-Altweck M, Blutke A, Polzin A, Stark K, Kaab S, Maier D, Gibbins JM, Limper U, Frobert O, Mann M, Massberg S, Petzold T. Immobility-associated thromboprotection is conserved across mammalian species from bear to human. Science. 2023 Apr 14;380(6641):178-187. doi: 10.1126/science.abo5044. Epub 2023 Apr 13.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism (VTE) and Acute Myocardial Infarction With ST Segment Elevation, run by University of Aarhus at 2 sites in 2 countries.
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 14 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathrine A Friis, MD, PhD-fellow (+45 20 65 27 32, katfrs@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet levels of heat shock protein 47 (HSP47) in patients with thrombosis compared to healthy controls (time frame: From enrollment to end of follow-up at 12 months after enrollment. At 3 time points.). 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 NCT06731673, 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 21 Aug 2025.