Clinical trial NCT05745428: Shear Stress Endothelial/Hemodynamics in Aortic Dissection and Endothelial Shear Stress-biological Profile
Official title: Shear Stress Endothelial/Hemodynamics in Aortic Dissection and Endothelial Shear Stress-biological Profile HADES-BP
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Keywords: hypertension
vasospasm
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants in this study present aortic dissection in its acute form (\< 14 days) leading to short-term complications such as aortic rupture and visceral malperfusion, while the subacute (15-90 days) and chronic (\> 90 days) forms lead to a process of aortic remodelling characterised by fibrinolysis and extracellular matrix (ECM) proteolysis, the latter being potential causes, in the long term, of gradual aortic dilatation with aneurysmal degeneration.

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.

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.

Eligibility criteria: Inclusion Criteria:

* partecipants admitted to our Department of Cardiovascular Sciences with a radiological diagnosis of AD within 14 days of the onset of symptoms;
* healthy outpatient or inpatient controls at our Department with another diagnosis and no evidence of AD, matched for demographic and clinical characteristics

Exclusion Criteria:

* evidence of inflammatory diseases, infectious diseases, neoplasms, immunological or haematological disorders;
* treatment with anti-inflammatory drugs with the exception of low-dose aspirin (75-160 mg);
* age \> 85 years;
* advanced chronic kidney disease with glomerular filtration rate (eGFR) estimated by MDRD equation \<30 ml/min./1.73 m2; 5) pregnancy;
* dissection with traumatic aetiology;
* failure to sign informed consent;

Primary outcomes:
measure: Evaluation of gene expression
timeFrame: 1 year
measure: Evaluation of transcriptomics
timeFrame: 1 year
measure: Evaluation of protein
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of correlation between circulating biomarkers
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References: