Heat Shock Protein 47 in Thrombosis

NCT06731673 | Recruiting

• 1 other identifier: HSP47
• Study Type: observational
• Target: 340
• Locations: 2 countries
• Sites: 2

Brief 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. 1.Are platelet levels of HSP47 higher in patients with acute VTE, AMI or stroke, compared to healthy volunteers.
2. 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. 3.Are platelet levels of HSP47 postively associated with platelet function and negatively associated with fibrinolytic capacity in patients with an acute thrombotic event.

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

Outcome Measures

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.

  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

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

• Platelet levels of HSP47 in association to platelet function

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

• Platelet levels of HSP47 in association to fibrinolytic capacity

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

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

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

Study Sites (2)

Aarhus University Hospital

Aarhus, Central Region, 8200, Denmark

RECRUITING

Deutsches Herzzentrum de Charité

Berlin, State of Berlin, 12203, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 37053338 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Venous Thromboembolism; Stroke

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Kathrine A Friis, MD, PhD-fellow

CONTACT

+45 20 65 27 32; katfrs@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); DK (1)