Heat Shock Protein 47 in Thrombosis

NCT ID: NCT06731673

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-09

Study Completion Date

2027-08-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Venous thromboembolism

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

No interventions assigned to this group

Acute myocardial infarction

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

No interventions assigned to this group

Stroke

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

No interventions assigned to this group

Healthy participants

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Max Planck Institute of Biochemistry

UNKNOWN

Sponsor Role collaborator

Deutsches Herzzentrum der Charité, Berlin

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus, Central Region, Denmark

Site Status RECRUITING

Deutsches Herzzentrum de Charité

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Denmark Germany

Central Contacts

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Kathrine A Friis, MD, PhD-fellow

Role: CONTACT

+45 20 65 27 32

Facility Contacts

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Kathrine A Friis, PhD-student

Role: primary

+45 20 86 75 94

Tobias Petzold, Prof., MD

Role: primary

+49 30- 450- 613745

References

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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 O, Mann M, Massberg S, Petzold T. Immobility-associated thromboprotection is conserved across mammalian species from bear to human. Science. 2023 Apr 14;380(6641):178-187. doi: 10.1126/science.abo5044. Epub 2023 Apr 13.

Reference Type BACKGROUND
PMID: 37053338 (View on PubMed)

Other Identifiers

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HSP47

Identifier Type: -

Identifier Source: org_study_id

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