跳至主要内容
临床试验/NCT06537934
NCT06537934招募中不适用

Advanced Mutidimensional and Ultra High Resolution Computed Tomography to Inspect Cardiopulmonary Involvement in Progressive Fibrosing Interstitial Lung Diseases

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
123
试验地点
1
主要终点
a low dose image protocol able to characterize ILD related lung parenchyma alteration and new quantitative imaging biomarkers of lung disease severity

研究概览

简要总结

Interstitial lung diseases (ILDs) are common chronic disease characterized by high mortality and morbidity, also linked to cardiovascular implication. Cardiovascular complications, occur early in idiopathic pulmonary fibrosis (IPF) and other ILDs without anysymptoms. Symptoms are often misinterpreted and diagnosis delayed to irreversible stages of cardiac dysfunction. Mechanism of cardiac damage, the main cause of mortality, are heterogeneous raging from ischemic heart disease, acceleration of atherosclerosis, to right ventricle dysfunction secondary, to pulmonary hypertension. So an early recognition and accurate staging are fundamental to avoid disease progression and improve outcomes. The identification of a single non-invasive imaging modality able to simultaneously characterize in an accurate and quantitative way the entity of lung and cardiac damage in patients affected by ILD would be useful to improve risk stratification and to guide treatment.

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

  • Adult subjects (>18 y.o.) with previously known ILD or high likelihood for having ILD including CTD diagnosis since at least 5 years before the project starts in order to increase the prevalence of ILD [2] who signed an Informed Consent authorizing data collection.

排除标准

  • Subjects with active infectious disease;
  • known CAD;
  • history of previous percutaneous or surgical revascularization;
  • known cardiomyopathy;
  • previous heart failure;
  • presence of cardiac devices (prosthetic valve, ICD, PM, ICD-CRT, LVAD)
  • previous or active neoplasia;
  • pregnancy and breastfeeding;
  • allergy to iodine contrast agent;
  • claustrophobia;
  • glomerular filtration rate < 30mL/min
  • impossibility to lay down or breath old
  • absence of informed consent signed

结局指标

主要结局

a low dose image protocol able to characterize ILD related lung parenchyma alteration and new quantitative imaging biomarkers of lung disease severity

时间窗: months 2-12

次要结局

  • the prevalence and the spectrum of cardiac disease (ischemic heart disease, cardiac remodelling and dysfunction in patients with ILD) and the relationship between severity of lung involvement and cardiac injury(months 3-16)
  • a CT based multiparametric algorithm for risk stratification of patients with ILD(months 19-24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Palmisano

Professor

IRCCS San Raffaele

研究点 (1)

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