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临床试验/NCT05285280
NCT05285280进行中(未招募)不适用

Prevalence and Risk Factors Associated With Cardiovascular Comorbidity in Men With Erectile Dysfunction

Herlev and Gentofte Hospital1 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
386
试验地点
1
主要终点
Number of reported cardiac arrest through medical records

研究概览

简要总结

Cardiovascular disease is the leading cause of morbidity and mortality in the world. To curb disease development, there is, therefore, a need to identify more people at increased risk. This can be done by advanced echocardiography, where the exact contraction pattern and dimensions of the heart are measured.

One group of patients who are already considered to be at increased risk for later development of heart disease are men with erectile dysfunction.

The investigators goal is to study the early detection of cardiac dysfunction in men with erectile dysfunction using both conventional and advanced echocardiography to analyze the possibility of preventing serious cardiovascular disease.

详细描述

Cardiovascular disease is the leading cause of morbidity and mortality across the globe. About 524,000 Danes live with cardiovascular disease and it affects approx. 56,400 people. In addition, many people live with heart problems without knowing it. These figures emphasize the importance of early identification of more people at increased risk of developing cardiovascular disease to prevent morbidity and mortality.

This can be done using advanced echocardiography, where the heart's precise contraction pattern, as well as structure and dimensions, are measured. One group of patients who are already considered to be at increased risk for later development of cardiovascular disease are men with erectile dysfunction (ED). ED is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. Approximately 30% of men over the age of 40 are affected by ED, and the incidence increases with age. ED is thought to be a precursor to cardiovascular disease, where it has been proven that after the onset of erection problems, over 3-5 years, there is an approximately 50% increased risk of cardiovascular disease.

The investigators hypothesize that cardiac structure and function assessed by conventional and advanced echocardiography together with cardiac biomarkers are abnormal in patients diagnosed with erectile dysfunction and can identify patients at high risk for cardiovascular complications. Echocardiography can serve as an important tool in risk assessment in these men who do not necessarily have symptom-causing problems.

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
40 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men above 40 years old diagnosed with ED will be eligible to participate if none of the exclusion criteria below are present.

排除标准

  • Patients not able to cooperate
  • Patients unable to understand and sign "informed consent"
  • Previous pelvic surgery (including prostatectomy, cystectomy and rectal surgery)
  • Neurological diseases (e.g. multiple sclerosis, spinal cord injury)
  • ED following pelvic trauma

结局指标

主要结局

Number of reported cardiac arrest through medical records

时间窗: 10 years

Number of reported coronary heart disease through medical records

时间窗: 10 years

Registration of: Coronary angiography

Number of reported ischemic heart disease through medical records

时间窗: 10 years

Number of reported hospital admission with heart failure through medical records

时间窗: 10 years

Number of reported hospital admission with acute myocardial infarction through medical records

时间窗: 10 years

Number of reported angina pectoris through medical records

时间窗: 10 years

Number of reported peripheral artery disease through medical records

时间窗: 10 years

Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).

次要结局

  • Number of reported all cause mortality(10 years)

研究者

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

Emil Durukan

Principal Investigator

Herlev and Gentofte Hospital

研究点 (1)

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