Controlled Trial of Serologic and Clinical Efficacy of Influenza Vaccine in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Influenza infection
研究概览
简要总结
This study wishes to understand:
- whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects;
- whether vaccination really decreases the episodes of influenza infection in those coronary artery disease patients who receive the vaccine than those who do not.
详细描述
Influenza infection may become complicated in patients with chronic conditions, including coronary artery disease (CAD) [1]. Influenza vaccination is now recommended as part of comprehensive secondary prevention in individuals with coronary and other atherosclerotic vascular disease (evidence level: Class I, Level B) [2]. Although there is controversial evidence pro [3,4] and against [5] the efficacy of influenza vaccination in protecting CAD population against cardiovascular events, the efficacy of vaccine in actual reduction in episodes of influenza infection and its fatal complications in CAD patients has not been, to our knowledge, well studied before. Furthermore, we found no report comparing serologic response to the influenza vaccine antigens between CAD patients and healthy controls.
This study aims to identify the efficacy of influenza vaccination in CAD individuals in terms of both serologic response (as compared with healthy individuals) and clinical outcomes (as compared with CAD patients not vaccinated).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Coronary artery disease (CAD) group (CAD-Exp and CAD-Control):
- •Patients with the diagnosis of acute, evolving or recent MI (after recovered the acute phase) as defined by:
- •Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:
- •Ischemic symptoms
- •Development of pathologic Qwaves on the ECG
- •ECG changes indicative of ischemia (ST segment elevation or depression); OR
- •Coronary artery intervention (e.g., coronary angioplasty).
- •Pathologic findings of an acute MI [1]:
- •Patients with stable angina pectoris (SA) and documented coronary artery stenosis (angiography).
- •Healthy Control group: healthy controls, proportionally matched by gender and age with the patient group (separate control groups for MI and SA patients).
排除标准
- •Any acute disease
- •Chronic liver or kidney diseases
- •Conditions accompanied by immunosuppression (like organ transplantation, HIV)
- •Diagnosed malignancy
- •Incubation with influenza vaccine within the past 5 years
- •Any psychological disease that interferes with regular follow-up
- •Congestive heart failure (Killip class IV)
- •Unstable angina; AND
- •Contradictions of vaccine incubation (like egg allergy).
结局指标
主要结局
Influenza infection
时间窗: 6 months
Serologic response (≥4-fold HI titer rise) to each of the 3 antigens of the trivalent vaccine of the 2006-07 campaign [Solomon Islands/3/2006(H1N1), Wisconsin/67/2005 (H3N2), and Malaysia/2506/2004 - like strains]
时间窗: 1 month
次要结局
- Magnitude of change in the antibody titer against each of the three influenza vaccine antigens(1 month)
- Protective antibody (≥1:40) titer after vaccination(1 month)
- Influenza-related death(6 months)