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NCT Number: NCT06731673

Heat Shock Protein 47 in Thrombosis

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.

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Key information

Conditions

Venous Thromboembolism (VTE) Acute Myocardial Infarction With ST Segment Elevation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Nervous System Diseases Stroke Stroke (in Patients With Atrial Fibrillation) Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Central Region, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • <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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry.

  2. Platelet levels of HSP47 in association to platelet function

    Time frame: From enrollment to 12 months of follow-up. Measured 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. Platelet function will be assessed by platelet aggregation and activation using impedance aggregometry and flow cytometry.

  3. Platelet levels of HSP47 in association to fibrinolytic capacity

    Time frame: From enrollment to 12 months of follow-up. Measured 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. Fibrinolytic capacity will be assessed by ROTEM (R) tPA methods established in our lab, and by plasma fibrinolysis analyses.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathrine A Friis, MD, PhD-fellow

CONTACT

[email protected]

+45 20 65 27 32

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Deutsches Herzzentrum der Charité, Berlin
  • Max Planck Institute of Biochemistry

Registry information

Official study title

Heat Shock Protein 47: A Novel Biomarker of Thrombosis Risk

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2024
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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