Shear Stress Endothelial/Hemodynamics in Aortic Dissection and Endothelial Shear Stress-biological Profile

NCT05745428 | Unknown

• 1 other identifier: 4626
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Dissection

Keywords

hypertension; vasospasm

Outcome Measures

Primary Outcomes (3)

• Evaluation of gene expression

  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.

  1 year

• Evaluation of transcriptomics

  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

  1 year

• Evaluation of protein

  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.

  1 year

Secondary Outcomes (1)

• Assessment of correlation between circulating biomarkers

  1 year

Study Arms (2)

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

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

Interventions

molecular and cellular analyses OTHER

sample blood

Also known as: Peripheral whole blood collection and isolation of mononuclear cells

Control Group; First group with aortic dissection

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

circulating biomarker analysis, aortic endothelial cell culture, peripheral whole blood collection and isolation of mononuclear cells

MeSH Terms

Conditions

Aortic Dissection; Hypertension

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 27, 2023
• Study Start: April 10, 2022
• Primary Completion: December 7, 2022
• Study Completion: April 16, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

IT (1)