Heat Shock Protein 47 in Thrombosis

University of Aarhus

Status: Not yet enrolling

Conditions: Stroke (in Patients With Atrial Fibrillation); Venous Thromboembolism (VTE); Acute Myocardial Infarction With ST Segment Elevation

Study type: Observational

Funder types: Other

Identifiers

NCT06731673

HSP47

Details and patient eligibility

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

340 participants in 4 patient groups

Venous thromboembolism

Description:

Patients with acute deep vein thrombosis diagnosed on UL or pulmonary embolism diagnosed on CTA. \>18 years of age. 120 patients in total.

Acute myocardial infarction

Description:

With ST segment elevation on ECG and confirmed culprit lesion on coronary angiography. \>18 years of age. 50 patients in total.

Stroke in relation to atrial fibrillation

Description:

Stroke confirmed on MRI and diagnosis of atrial fibrillation. \>18 years of age. 50 patients in total.

Healthy participants

Description:

No known or prior diseases, no medication. \>18 years of age. 120 in total.