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Recruiting NCT06731673

Heat Shock Protein 47 in Thrombosis

— Observational Venous Thromboembolism (VTE) Acute Myocardial Infarction With ST Segment Elevation Stroke (in Patients With Atrial Fibrillation)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Venous Thromboembolism (VTE), Acute Myocardial Infarction With ST Segment Elevation, Stroke (in Patients With Atrial Fibrillation). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Heat Shock Protein 47: A Novel Biomarker of Thrombosis Risk

Overview

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.

Primary outcome measures

  • Platelet levels of heat shock protein 47 (HSP47) in patients with thrombosis compared to healthy controls [Time frame: From enrollment to end of follow-up at 12 months after enrollment. At 3 time points.]
Secondary outcome measures (3)
  • Changes in platelet levels of HSP47 over time in patients with thrombosis [Time frame: From enrollment to 12 months of follow-up. Measured at 3 time points.]
  • Platelet levels of HSP47 in association to platelet function [Time frame: From enrollment to 12 months of follow-up. Measured at 3 time points.]
  • Platelet levels of HSP47 in association to fibrinolytic capacity [Time frame: From enrollment to 12 months of follow-up. Measured at 3 time points.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Aarhus University Hospital — Aarhus
Germany · 1 center
  • Deutsches Herzzentrum de Charité — Berlin

Publications

  • Thienel M, Muller-Reif JB, Zhang Z, Ehreiser V, Huth J, Shchurovska K, Kilani B, Schweizer L, Geyer PE, Zwiebel M, Novotny J, Lusebrink E, Little G, Orban M, Nicolai L, El Nemr S, Titova A, Spannagl M, Kindberg J, Evans AL, Mach O, Vogel M, Tiedt S, Ormanns S, Kessler B, Dueck A, Friebe A, Jorgensen PG, Majzoub-Altweck M, Blutke A, Polzin A, Stark K, Kaab S, Maier D, Gibbins JM, Limper U, Frobert PMID 37053338

Identifiers

NCT: NCT06731673 · HSP47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗