Clinical trial NCT06731673: Heat Shock Protein 47 in Thrombosis
Official title: Heat Shock Protein 47: A Novel Biomarker of Thrombosis Risk
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Max Planck Institute of Biochemistry
name: Deutsches Herzzentrum der Charité, Berlin
First posted: 2024-12-12
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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. 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: 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

Primary outcomes:
measure: Platelet levels of heat shock protein 47 (HSP47) in patients with thrombosis compared to healthy controls
timeFrame: From enrollment to end of follow-up at 12 months after enrollment. At 3 time points.
Secondary outcomes:
measure: Changes in platelet levels of HSP47 over time in patients with thrombosis
timeFrame: From enrollment to 12 months of follow-up. Measured at 3 time points.
measure: Platelet levels of HSP47 in association to platelet function
timeFrame: From enrollment to 12 months of follow-up. Measured at 3 time points.
measure: Platelet levels of HSP47 in association to fibrinolytic capacity
timeFrame: From enrollment to 12 months of follow-up. Measured at 3 time points.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.