Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA) (IPaNeMA)

Investigation of the Neurovegetative Pattern in the Adult Population With Thoracic Aortic Aneurysms (AAT)

The goal of this observational cross-sectional study is to learn about vagal features in patients with syndromic and non-syndromic TAA. The main question it aims to answer is to highlight a functional condition that could help stratify patients with TAA on the risk of aortic complications.

Participant will take part by standing in supine position for 10 minutes and during active standing for 10 minutes. In this period of time, it will be possible to acquire the signals continuously and non invasively through recorded non-invasive blood pressure and piezoelectric sensor breathing belt.

Study Overview

• Status: Active, not recruiting
• Conditions: Rare Diseases; Aortic Aneurysm, Thoracic
• Intervention / Treatment: Diagnostic test: Supine resting (REST) and active standing (STAND)

Detailed Description

Changes in blood pressure (BP) are tightly controlled by a neural surveillance system that triggers changes in response to heart rate, vascular tone, and respiration.

Therefore, studies in literature have investigated the regulatory effects of the sympathetic system on the tone of the vessels as well as on the BP, but further analysis are needed in order to describe its potential impact on the structure of the aortic wall and, in particular, its potential implications on aneurysms and risk of aortic dissections.

Considering that, in the population with TAA, the neurovegetative pattern influences the responses to different stressors (environmental, occupational and emotional) and also acts on the BP, which represents a risk factor for the TAA population, its analysis would allow to identify attitudes and behavioral predispositions and therefore response to stressors.

The non-invasive analysis of sympatho-adrenergic patterns could help to highlight a functional condition related to the "environmental stressors" which could help to stratify patients with TAA based on the level of pathological reactivity with effects on risk of aortic complications.

• Study Type: Observational
• Enrollment (Estimated): 139

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • San Donato Milanese, Lombardy, Italy, 20097
      • IRCCS Policlinico San Donato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic, hospitals.

Description

Inclusion Criteria:

• Patients aged 18-65 years with syndromic and nonsyndromic TAA;
• Signed informed consent;
• Patients on regular pharmacological prophylaxis (with Losartan) or naïve patients with a first diagnosis

Exclusion Criteria:

• Acute and chronic inflammatory diseases such as: liver disease, chronic renal insufficiency (creatinine > 1.5 mg/dl) and diseases affecting the thyroid system.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Syndromic TAA; Patients presenting either clinical or genetic phenotype referring to a syndrome related to Thoracic Aortic Aneurysms	Diagnostic test: Supine resting (REST) and active standing (STAND); Analysis of baroreflex sensitivity
Non-syndromic TAA; Patients presenting Thoracic Aortic Aneurysms	Diagnostic test: Supine resting (REST) and active standing (STAND); Analysis of baroreflex sensitivity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supine resting (REST) and active standing (STAND)	Baroreflex sensitivity	18 months

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato
• Collaborators: Politecnico di Milano

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): October 25, 2024
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Autonomic Nervous System; Thoracic Aneurysms; Heart rate Variability
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Aortic Diseases; Aneurysm; Aortic Aneurysm; Pathological Conditions, Signs and Symptoms; Rare Diseases; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: IPaNeMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No