Heat Shock Protein 47 in Thrombosis

Not yet recruiting

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

• Registration Number: NCT06731673
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-09
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.