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RecruitingNCT06731673Updated Aug 21, 2025

Heat Shock Protein 47 in Thrombosis

An observational study in Venous Thromboembolism (VTE), Acute Myocardial Infarction With ST Segment Elevation and Stroke (in Patients With Atrial Fibrillation), sponsored by University of Aarhus. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-21.

Sponsored by University of Aarhus · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
340
Ages
18 Years and older
Sex
All
01

Study 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. The main questions it aims to answer are:

  1. Are platelet levels of HSP47 higher in patients with acute VTE, AMI or stroke, compared to healthy volunteers.
  2. 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.
  3. 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.

02

Conditions studied

  • 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
03

In context

Venous Thromboembolism

694 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.

This study's planned enrollment of 340 is below the median of 700 across 283 observational studies indexed under Venous Thromboembolism.

Browse Venous Thromboembolism studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

Inclusion criteria

  • 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:

  • 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

Exclusion criteria

Exclusion Criteria:

  • \<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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
340 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to end of follow-up at 12 months after enrollment. At 3 time points.

Secondary outcomes

  1. 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.

    Time frame: From enrollment to 12 months of follow-up. Measured at 3 time points.

  2. 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.

    Time frame: From enrollment to 12 months of follow-up. Measured at 3 time points.

  3. 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.

    Time frame: From enrollment to 12 months of follow-up. Measured at 3 time points.

07

Study locations

2 of 2 sites recruiting
  • Aarhus University Hospital
    Aarhus, Central Region 8200, Denmark
    • Kathrine A Friis, PhD-student · Contact · kathrinefriis@live.dk · +45 20 86 75 94
    • Erik L Grove, Assoc. Prof., MD · Principal investigator
    • Kathrine A Friis, MD, PhD-fellow · Sub investigator
    Recruiting
  • Deutsches Herzzentrum de Charité
    Berlin, State of Berlin 12203, Germany
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06731673
Lead sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Max Planck Institute of Biochemistry, Deutsches Herzzentrum der Charité, Berlin
Responsible party
Sponsor
First posted
Dec 12, 2024
Start date
Dec 9, 2024
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Aug 21, 2025

Study contacts

Kathrine A Friis, MD, PhD-fellow
Contact
katfrs@rm.dk
+45 20 65 27 32

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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