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临床试验/NCT07105501
NCT07105501已完成不适用

Hidden Auricular Amyloid Deposits and Aortic Stenosis: Clinical and Prognostic Implications in Aortic Valve Replacement Surgery

Germans Trias i Pujol Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
NT-proBNP levels

研究概览

简要总结

Background (Context):

Some older adults who undergo surgery to replace a narrowed heart valve (called aortic stenosis) may also have small protein deposits in their heart. These protein clumps, known as amyloid, are more often found in people with a certain condition called amyloidosis. However, in many cases, these deposits are found only in the upper chambers of the heart (called atria) and without any previous diagnosis of the disease. The meaning and health impact of these hidden amyloid deposits are still unclear.

Objectives (What the investigators wanted to find out):

This study aimed to understand how common these protein deposits are in people with aortic valve disease, what this deposits are made of, and how they affect recovery and health after heart surgery. To do this, various types of analysis were combined, including tissue samples, blood tests, and advanced genetic studies.

Methods (What the investigators did):

Seventy patients undergoing surgery to replace the aortic valve were studied. During the operation, small samples were collected from the top part of the heart and analyzed in the lab using special dyes and microscopes. Substances in blood were also measured, and health status was monitored over the following year. For some samples, advanced genetic tools were used to investigate processes at the level of individual cells.

详细描述

The study aims to find out whether deposits of amyloid (an abnormal protein that builds up in tissues) in the upper chambers of the heart are linked to worse recovery after aortic valve replacement surgery. For example, it looks at whether these deposits are related to hospital readmissions, irregular heart rhythms, or problems with kidney function after surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years of age.
  • Signed specific informed consent (see attached).
  • Severe aortic stenosis with surgical indication.
  • Elective isolated aortic valve replacement surgery via full or partial median sternotomy.

排除标准

  • Urgent or emergency surgery (patients in cardiogenic shock, under intra-aortic balloon pump therapy or any other mechanical support, or receiving vasoactive drugs).
  • Combined surgery with any additional procedure.
  • Ischemic heart disease with significant lesions confirmed by preoperative invasive catheterization, with or without concomitant revascularization during aortic valve replacement surgery.
  • Concomitant endocarditis.
  • Inability to collect surgical tissue samples. Initially, all patients with at least one histological sample were included; later, only those with both atrial and septal samples were analyzed.
  • Extracardiac disease with a life expectancy of less than 365 days.
  • Patient with a previous and/or current diagnosis of any form of amyloidosis.
  • Surgical access other than full or partial median sternotomy.
  • Patients with severe aortic stenosis but with a TAVI indication as decided by a multidisciplinary heart team (including interventional cardiology, clinical cardiology, and cardiac surgery).

结局指标

主要结局

NT-proBNP levels

时间窗: From enrollment to the one-year follow-up

NT-proBNP preoperative and follow-up levels in each group

Hospital readmission

时间窗: From enrollment to the one - year follow-up

Hospital readmission in the first year follow-up

Metrnl levels

时间窗: from enrollment to the one-year follow-up

Metrnl preoperative and follow up levels

New-onset postoperative atrial fibrillation

时间窗: From enrollment to the one-year follow-up

New presence of postoperative atrial fibrillation

Postoperative quality of life

时间窗: From enrollment to the one-year follow-up

Use of the EuroQuol subjectives health test preoperatively and at one-year follow-up. The test completed title is EuroQuol 5D-5L (or EQ-5D-5L), and it consists of a final score ranging from 0 to 100 points, with 0 representing the worst possible health and 100 the best.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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