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临床试验/NCT03599414
NCT03599414已完成不适用

CASPA (CArdiac Sarcoidosis in PApworth): Improving the Diagnosis of Cardiac Disease in Patients With Pulmonary Sarcoidosis

Papworth Hospital NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年6月29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
104
试验地点
1
主要终点
The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis

研究概览

简要总结

Sarcoidosis is a disease of unknown cause which affects adults of all ethnic backgrounds. Clumps of tissue called granulomas develop primarily in the lungs, but can damage other organs, especially the heart. Anecdotal evidence from autopsy studies suggests the heart is affected in up to 68% of patients, but there is much uncertainty about this figure.

If undetected and untreated, it can lead to serious complications or even sudden death. The current recommendation is to perform heart tracings (ECG s) on all patients, but this detects fewer than half of those with heart involvement.

Blood markers traditionally used to diagnose heart disease are unreliable, meaning there is no simple blood test in use.

The investigators propose a study with three aims. Firstly, identify the true prevalence of heart disease by performing Magnetic Resonance Imaging (MRI) scans on a group of patients with newly diagnosed lung sarcoidosis. Those found to have heart disease will have specialist (but routine) electrical heart tests. Secondly, (and perhaps the most immediate and clinically relevant) to identify the best method of diagnosing heart involvement using a combination of three simple tests: advanced ECG, 24-hour continuous ECG and a new type of computerised ultrasound scan. Thirdly, to identify proteins in the blood that could be used to develop a simple blood test for heart involvement in patients with lung sarcoidosis.

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

  • Newly referred adult patients with pulmonary sarcoidosis and diagnosis made at multidisciplinary meeting as per current joint BTS/ATS guidance
  • Patient may be on ≤10mg prednisolone at time of recruitment (if already started at another site prior to referral).
  • Able to give informed consent and able to comply with protocol
  • ≥>18 yrs

排除标准

  • History of other cardiac disease (e.g. coronary artery disease)cardiac surgery or previous myocardial infarction (MI)
  • Inability to give informed consent
  • Patient may be on >10mg prednisolone at time of recruitment (if already started at another site prior to referral).
  • On non-steroidal medication including methotrexate
  • Pregnancy
  • Alcoholism
  • Illicit drug abuse
  • Exclusion criteria for MRI:
  • Cardiac pacemakers
  • Surgical clips in the head (particularly aneurysm clips)
  • Electronic inner ear implants (bionic ears)
  • Ocular metal fragments • Electronic stimulators • Implanted pumps
  • Severe claustrophobia

结局指标

主要结局

The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis

时间窗: on Day 1

The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis

次要结局

  • Cytokine and Proteomic profiling(after 1 year)
  • Diagnosis of cardiac sarcoidosis(on Day 1)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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CASPA: CArdiac Sarcoidosis in PApworth | 临床试验