| NCT ID | NCT06731673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Venous Thromboembolism (VTE) |
| Study Type | OBSERVATIONAL |
| Enrollment | 340 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 340 participants in total. It began in 2024-12-09 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06731673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboembolism (VTE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06731673 currently recruiting?
Yes, NCT06731673 is actively recruiting participants. Contact the research team at katfrs@rm.dk for enrollment information.
Where is the NCT06731673 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Berlin, Germany.
Who is sponsoring the NCT06731673 clinical trial?
NCT06731673 is sponsored by University of Aarhus. The trial plans to enroll 340 participants.