흉부대동맥류(TAA) 환자의 신경생장 양상에 대한 조사 (IPaNeMA)
흉부 대동맥류(AAT)가 있는 성인 인구의 신경생식 패턴 조사
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Lombardy
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San Donato Milanese, Lombardy, 이탈리아, 20097
- IRCCS Policlinico San Donato
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Primary care clinic, hospitals.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Syndromic TAA
Patients presenting either clinical or genetic phenotype referring to a syndrome related to Thoracic Aortic Aneurysms |
Analysis of baroreflex sensitivity |
|
Non-syndromic TAA
Patients presenting Thoracic Aortic Aneurysms |
Analysis of baroreflex sensitivity |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Supine resting (REST) and active standing (STAND)
기간: 18 months
|
Baroreflex sensitivity |
18 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .