Heat shock protein 47 in blood clot conditions
Heat Shock Protein 47: A Novel Biomarker of Thrombosis Risk
This will test whether platelet levels of Heat Shock Protein 47 (HSP47) can help predict outcomes in adults with recent venous thromboembolism, ST-elevation myocardial infarction, or ischemic stroke compared with healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus, Central Region and 1 other locations) |
| Trial ID | NCT06731673 on ClinicalTrials.gov |
What this trial studies
This observational study will measure platelet HSP47 levels in adults presenting with acute VTE, ST-elevation myocardial infarction, or ischemic stroke and compare them to healthy volunteers. Patients will provide blood samples at diagnosis and again at 3 and 12 months, while healthy volunteers give a single sample. The study will compare acute versus follow-up HSP47 levels and examine associations between HSP47, platelet function, and fibrinolytic capacity. The work is conducted at participating centers in Denmark and Germany.
Who should consider this trial
Good fit: Adults aged 18 or older with confirmed DVT or PE, ST-elevation myocardial infarction with a culprit coronary lesion on angiography, or ischemic stroke with atrial fibrillation and the specified imaging features who can give informed consent are ideal candidates.
Not a fit: People with known hematological disorders, active hematological malignancy, severe renal failure (eGFR <15 or on dialysis), incidental PE without DVT, or who do not meet the acute event definitions are unlikely to benefit from this biomarker-focused protocol.
Why it matters
Potential benefit: If HSP47 reliably marks thrombotic activity, it could help identify patients at higher risk of recurrent clots and guide monitoring or preventive treatment.
How similar studies have performed: HSP47 has been studied in fibrosis and platelet biology but has not been widely validated as a clinical prognostic biomarker for thrombotic disease, so this is a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus, Central Region and 1 other locations
- Aarhus University Hospital — Aarhus, Central Region, Denmark (Recruiting)
- Deutsches Herzzentrum de Charité — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Kathrine A Friis, MD, PhD-fellow
- Email: katfrs@rm.dk
- Phone: +45 20 65 27 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.