Heat Shock Protein 47 in Thrombosis
Recruiting · NCT06731673 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed.
- Aarhus University Hospital - Aarhus, Central Region, Denmark
- Deutsches Herzzentrum de Charité - Berlin, State of Berlin, Germany