Immobility-associated thromboprotection is conserved across mammalian species from bear to human.
Manuela Thienel, Johannes B Müller-Reif, Zhe Zhang...
https://pubmed.ncbi.nlm.nih.gov/37053338Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID06731673
Heat Shock Protein 47: A Novel Biomarker of Thrombosis Risk
Led by University of Aarhus · Updated on 2025-08-21
340
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether the novel biomarker Heat Shock Protein 47 (HSP47) can serve as a prognostic marker for vascular disease in people who have experienced acute venous thromboembolism (VTE), acute myocardial infarction (AMI), or ischemic stroke, compared to healthy volunteers. The study aims to determine if platelet levels of HSP47 are higher in these patients at diagnosis and whether these levels remain elevated at 3 and 12 months after the event. It also explores the relationship between HSP47 levels, platelet function, and fibrinolytic capacity in patients with acute thrombotic events. This observational study includes four groups: patients with acute VTE diagnosed by ultrasonography or pulmonary embolism diagnosed by CT angiography; patients with ST segment elevation myocardial infarction confirmed by coronary angiography; patients with stroke confirmed by MRI and atrial fibrillation; and healthy participants with no known diseases or medications. Patients provide blood samples at diagnosis and again at 3 and 12 months, while healthy volunteers provide a single blood sample. Participants will undergo blood sampling and monitoring for platelet levels of HSP47 and related platelet function over the study period. The primary outcome is the comparison of platelet HSP47 levels between patients and healthy controls at diagnosis and follow-up. Secondary outcomes include changes in HSP47 over time and its associations with platelet function and fibrinolytic capacity. The study is sponsored by the University of Aarhus and will continue until August 2027.
CONDITIONS
Brief Title
Heat Shock Protein 47 in Thrombosis
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Informed consent provided
- For VTE group: Deep vein thrombosis confirmed by ultrasonography or pulmonary embolism confirmed by CT angiography
- For AMI group: ST segment elevation on ECG and culprit lesion(s) confirmed by coronary angiography
- For Stroke group: Stroke confirmed by MRI, atrial fibrillation detected by ECG, telemetry, or Holter monitoring, and stroke location consistent with atrial fibrillation
- For Healthy group: Generally healthy with no known diseases or medications
You will not qualify if you...
- Younger than 18 years
- No informed consent
- Known blood disorders
- Active blood-related cancers
- Severe kidney failure defined as eGFR less than 15 or requiring dialysis
- For VTE group: Pulmonary embolism incidentally found without deep vein thrombosis
- For AMI group: Coronary dissection or Takotsubo cardiomyopathy
- For Stroke group: Stroke caused by other reasons such as large vessel disease
- For Healthy group: Known acute or chronic disease or previous thromboembolic events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to enrollment
Participants undergo diagnostic procedures to confirm their health status or specific thrombosis conditions according to their group assignment.
1 to 2 visits depending on diagnostic confirmation
Long-term Monitoring
Duration - 12 months
Participants are monitored over 12 months with assessments of platelet levels of heat shock protein 47 and related platelet function at three time points.
3 visits over 12 months
Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus, Central Region, Denmark, 8200
Actively Recruiting
2
Deutsches Herzzentrum de Charité
Berlin, State of Berlin, Germany, 12203
Actively Recruiting
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Research Team
K
Kathrine A Friis, MD, PhD-fellow
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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