Heat Shock Protein 47 in Thrombosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years of age or older

Informed consent

Deep vein thrombosis confirmed on ultrasonography OR

Pulmonary embolism confirmed on computed tomography angiography (CTA)

Disqualifiers

<18 years of age

no informed consent

Known haematological disorders

Active haematological malignancy

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

340 Participants
are grouped into 4 trial groups
Group A: Venous thromboembolism
Group B: Acute myocardial infarction
Group C: Stroke
Group D: Healthy participants

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator

Max Planck Institute of Biochemistry

Collaborator

Deutsches Herzzentrum der Charité, Berlin

Collaborator