Study Results
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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RECRUITING
340 participants
OBSERVATIONAL
2024-12-09
2027-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
Max Planck Institute of Biochemistry
UNKNOWN
Deutsches Herzzentrum der Charité, Berlin
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University Hospital
Aarhus, Central Region, Denmark
Deutsches Herzzentrum de Charité
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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HSP47
Identifier Type: -
Identifier Source: org_study_id
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