Acute Myocardial Infarction With ST Segment Elevation, Stroke (in Patients With Atrial Fibrillation), Venous Thromboembolism (VTE)
Conditions
Keywords
HSP47, Heat Shock Protein 47, Biomarker, Novel biomarker, Trombosis, VTE, AMI, Stroke
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.
Interventions
None listed
Sponsors
Aarhus University Hospital
Max Planck Institute of Biochemistry
Deutsches Herzzentrum der Charité, Berlin
University of Aarhus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet levels of heat shock protein 47 (HSP47) in patients with thrombosis compared to healthy controls | From enrollment to end of follow-up at 12 months after enrollment. At 3 time points. | The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry. |
| Platelet levels of HSP47 in association to platelet function | From enrollment to 12 months of follow-up. Measured at 3 time points. | The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry. Platelet function will be assessed by platelet aggregation and activation using impedance aggregometry and flow cytometry. |
| Platelet levels of HSP47 in association to fibrinolytic capacity | From enrollment to 12 months of follow-up. Measured at 3 time points. | The level of HSP47 on platelets will be measured in a bloodsample. It will be measured using proteomics and flow cytometry. Fibrinolytic capacity will be assessed by ROTEM (R) tPA methods established in our lab, and by plasma fibrinolysis analyses. |
Countries
Denmark, Germany
Contacts
Primary ContactKathrine A Friis, MD, PhD-fellow
Outcome results
None listed