Aortic DissectionHADES-BPNCT05745428
Shear Stress Endothelial/Hemodynamics in Aortic Dissection and Endothelial Shear Stress-biological Profile
An observational study of Aortic Dissection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- molecular and cellular analyses
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2022to 16 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
About this study
Official title: Shear Stress Endothelial/Hemodynamics in Aortic Dissection and Endothelial Shear Stress-biological Profile HADES-BP
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.
Read the 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.
- Conditions
- Aortic Dissection
- Being tested
- molecular and cellular analyses
- Keywords
- hypertension, vasospasm
- Medical subject headings
- Aortic Dissection, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecular and cellular analysesOther
Also called Peripheral whole blood collection and isolation of mononuclear cells
sample blood
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: molecular and cellular analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
Assessment of correlation between circulating biomarkers
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start10 Apr 2022
- Primary completion7 Dec 2022
- Study completion16 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedicino Daniela, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745428
- Sponsor's protocol ID
- 4626
- Acronym
- HADES-BP
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Stress Endothelial/Hemodynamics in Aortic Dissection and Endothelial Shear Stress-biological Profile HADES-BP
- ClinicalTrials.gov ID
- NCT05745428
- Acronym / sponsor ID
- HADES-BP / 4626
- Conditions
- Aortic Dissection
- Keywords
- hypertension, vasospasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 16 Apr 2024 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First group with aortic dissection | – | Other: molecular and cellular analyses19 patients admitted to our Department of Cardiovascular Sciences with a radiological diagnosis of AD within 14 days of the onset of symptoms |
| Control Group | – | Other: molecular and cellular analyses19 healthy outpatient or inpatient controls at our Department with another diagnosis and no evidence of AD, matched for demographic and clinical characteristics. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecular and cellular analysesAlso: Peripheral whole blood collection and isolation of mononuclear cellssample blood | Other | Control Group, First group with aortic dissection |
Primary outcome
Evaluation of gene expression
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Assessment of correlation between circulating biomarkers
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of gene expression (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.