HADES-BP: Shear Stress Endothelial/Hemodynamics in Aortic Dissection and Endothelial Shear Stress-biological Profile
Study Details
Study Description
Brief Summary
Aortic dissection (AD) is a clinical condition belonging to the broader spectrum of Acute Aortic Syndromes, with high morbidity and mortality and characterised by the sudden formation of a breach within the tonaca intima of the aortic wall, from which the so-called false lumen originates.The most common risk factor for AD is hypertension, present in more than 70% of.
Imaging, biomarkers and genetic predisposition are critical in confirming a suspected diagnosis and in determining the appropriate intervention for each patient. Specific features influencing management decisions are the presence of rupture, extent of dissection, origin of true or false lumen vessels and signs of organ ischaemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The aim of this study is to investigate the diagnostic value of circulating biomarkers and in aortic tissue in patients with AD and to assess the prognosis of patients with AD and its complications in relation to the aforementioned markers, integrating biological data with clinical and instrumental data relating to the patient's hospitalisation.
The study involves a comparison between two arms, one experimental and the other control (healthy outpatients). A longitudinal evaluation will be carried out on the experimental arm with a follow-up visit (FUp) at 3, 6 and 12 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| First group with aortic dissection 19 patients admitted to our Department of Cardiovascular Sciences with a radiological diagnosis of AD within 14 days of the onset of symptoms |
Other: molecular and cellular analyses
sample blood
Other Names:
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| Control Group 19 healthy outpatient or inpatient controls at our Department with another diagnosis and no evidence of AD, matched for demographic and clinical characteristics. |
Other: molecular and cellular analyses
sample blood
Other Names:
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Outcome Measures
Primary Outcome Measures
- Evaluation of gene expression [1 year]
Evaluation of gene expression (by RT-qPCR),the analysis of circulating biomarkers smMYO11 (Human Myosin Heavy Chain 11, SmoothMuscle (MYH11) ELISA Kit, My Biosource), Calponin (Human Calponin-1 ELISA Kit, My Biosource) and MMP-9 (Human MMP-9 Quantikine ELISA Kit, R&D System ) will be performed by enzyme immunoassay on suitably preserved serum from AD and CTRL partecipants, in accordance with the manufacturer's instructions.
- Evaluation of transcriptomics [1 year]
This study will be perfomed by single-cell analysis with enzyme immunoassay thanks to the peripheral blood sample that was taken from the participant at the time of enrollment
- Evaluation of protein [1 year]
This evaluation immunoenzymatic analyses, it's important to analyze altered biomarkers following fluid dynamic alterations applied by controlled mechanical stress to a model of primary cultures of aortic endothelial cells (HAOEC) and peripheral mononuclear cells (PBMC) isolated from enrolled subjects.
Secondary Outcome Measures
- Assessment of correlation between circulating biomarkers [1 year]
Assessment of correlation between circulating biomarkers, clinical data (signs of haemodynamic stability such as blood pressure (BP), heart rate (HR), oxygen saturation (SpO2), signs of organ malperfusion such as neurological signs distal pulses, oligo-anuria or signs of outward rupture such as cardiac tamponade, acute aortic valvular insufficiency, haemothorax, haemoperitoneum), and imaging data (diameter of the ascending aorta ≥5 5cm, intimal breach size >10mm, diameter of the false lumen >22mm, partial thrombosis of the false lumen, intimal flap concave towards the false lumen, periaortic haematoma, single entry port or localisation of this in the small curvature of the aortic arch)
Eligibility Criteria
Criteria
Inclusion Criteria:
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partecipants admitted to our Department of Cardiovascular Sciences with a radiological diagnosis of AD within 14 days of the onset of symptoms;
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healthy outpatient or inpatient controls at our Department with another diagnosis and no evidence of AD, matched for demographic and clinical characteristics
Exclusion Criteria:
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evidence of inflammatory diseases, infectious diseases, neoplasms, immunological or haematological disorders;
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treatment with anti-inflammatory drugs with the exception of low-dose aspirin (75-160 mg);
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age > 85 years;
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advanced chronic kidney disease with glomerular filtration rate (eGFR) estimated by MDRD equation <30 ml/min./1.73 m2; 5) pregnancy;
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dissection with traumatic aetiology;
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failure to sign informed consent;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4626