ENDO-CARE: Endocarditis Clinical Awareness, Research, and Evaluation in Sweden
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22,000
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
The goal of this observational study is to improve the understanding of infective endocarditis by investigating clinical characteristics, treatment strategies, and short- and long-term outcomes in patients diagnosed with infective endocarditis in Sweden. The study includes all adults >18 years of age diagnosed with infective endocarditis in Sweden since 1997 through linkage of nationwide Swedish health data registers within the Endocarditis Clinical Awareness, Research and Evaluation in Sweden (ENDO-CARE) project. For each patient, four individuals from the general population matched on age and sex are included as population comparators.
The main questions it aims to answer are:
- Which patients with infective endocarditis benefit from valve surgery, and what is the optimal timing of surgery?
- Which patient-, disease-, microbiological-, and socioeconomic factors are associated with short- and long-term outcomes, including mortality, recurrent infective endocarditis, heart failure, stroke, and other major complications?
- How do long-term outcomes and life expectancy differ between patients with infective endocarditis and matched individuals from the general population?
- How have the incidence, management, microbiology, and outcomes of infective endocarditis changed over time?
Researchers will compare surgically and non-surgically treated patients, different clinical subgroups, and patients with infective endocarditis with matched population comparators to identify factors associated with treatment decisions, prognosis, and long-term outcomes.
Participants will not undergo any study-specific interventions or examinations. The study is based on linkage of existing nationwide Swedish health care and population registers, including data on hospital admissions, cardiac surgery, microbiology, prescribed medications, dental care, socioeconomic factors, and causes of death.
详细描述
Infective endocarditis (IE) is a rare but life-threatening disease associated with high morbidity and mortality despite advances in diagnostic methods, antimicrobial therapy, and cardiac surgery. Although current international guidelines provide recommendations concerning management of patients with infective endocarditis, many important clinical questions remain unanswered because randomized clinical trials are difficult to perform in this patient population. Consequently, most evidence is derived from observational studies, which are often limited by small sample sizes, selected patient populations, and relatively short follow-up.
The Endocarditis Clinical Awareness, Research and Evaluation in Sweden (ENDO-CARE) project is a nationwide research platform established to improve the understanding of infective endocarditis through comprehensive linkage of Swedish national health data registers. The ENDO-CARE database includes all patients diagnosed with infective endocarditis in Sweden since 1997. In addition, four matched individuals from the general population are included for each patient to enable comparisons of long-term outcomes and life expectancy with the background population.
The database integrates information from multiple nationwide registers, including hospital admissions, diagnoses, cardiac surgery, microbiology, echocardiographic findings, prescribed medications, socioeconomic factors, dental care, causes of death, and other population-based health registers. Individual-level linkage is performed using the unique Swedish personal identity number before data are pseudonymized for research purposes.
The overall objective of ENDO-CARE is to broaden the knowledge about endocarditis and to improve the evidence base for the management of infective endocarditis. Planned studies will investigate patient characteristics, microbiology, cardiac imaging findings, treatment strategies, and both short- and long-term outcomes.
Particular emphasis will be placed on:
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
- 是
入选标准
- •Patients aged >18 years diagnosed with infective endocarditis in Sweden from January 1, 1997, and onwards, identified through nationwide Swedish health data registers.
- •Individuals from the general population matched to patients with infective endocarditis (four comparators per patient) on age and sex.
排除标准
- •Individuals with missing or invalid personal identity numbers precluding linkage between national registers.
- •Individuals with incomplete or inconsistent registry information preventing determination of study eligibility or follow-up, where applicable to specific analyses.
研究组 & 干预措施
Patients with infective endocarditis
Matched controls from the general population
结局指标
主要结局
All-cause mortality
时间窗: 20 years
All-cause mortality
时间窗: From index diagnosis until end of available follow-up (up to 28 years)
次要结局
- Heart failure(20 years)
- Stroke(20 years)
- Major bleeding(20 years)
- Re-infection(20 years)
- Repeat valve surgery(20 years)
- Cardiovascular death(20 years)
- Cardiovascular death(From index diagnosis until end of available follow-up (up to 28 years))
- Heart failure(From index diagnosis until end of available follow-up (up to 28 years))
- Stroke(From index diagnosis until end of available follow-up (up to 28 years))
- Major bleeding(From index diagnosis until end of available follow-up (up to 28 years))
- Re-infection(From index diagnosis until end of available follow-up (up to 28 years))
- Repeat valve surgery(From index diagnosis until end of available follow-up (up to 28 years))
研究者
Natalie Glaser
Principal Investigator
Karolinska Institutet