Collection of Long-Term Follow-up Medical Events in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Prevalence of cardiovascular events
研究概览
简要总结
The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).
Currently, we do not have long-term follow-up data for these patients.
The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.
Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.
详细描述
The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).
The 9 studies were referred as : ADISAS (NCT011968), AGIRSASADOM (NCT010902), BPCO (NCT004044), BPCO-SAS (NCT01195064), DIAMETASAS, Aortic Dissection (NCT01068691), INFRASAS (NCT010892), VALSAS (NCT004094), NIV-OHS (NCT006030).
The objective of this meta-analysis on individual data was to understand the relationship between the severity of the sleep apnea syndrome (measured by the apnea + hypopnea index) and arterial rigidity at the time of diagnosis of SAS.
Currently, we do not have long-term follow-up data for these patients.
The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.
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
- 否
入选标准
- •already included in the meta-analysis "sleep apnea syndrome and arterial stiffness".
排除标准
- •refusal to participate
- •family not reachable and death not identified in the Hospital medical base
- •persons under judicial protection (article L1122-2 of the Public Health Code) and patients under guardianship or curatorship
结局指标
主要结局
Prevalence of cardiovascular events
时间窗: up to 15 years
Prevalence of cardiovascular events during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.
次要结局
- Effect of CPAP treatment on the metabolic events occurrence(during 6 months)
- Prevalence of deaths(up to 15 years)
- Prevalence of metabolic events(up to 15 years)
- Effect of CPAP treatment on the cardiovascular events occurrence(during 6 months)
- Prevalence of incident cancers(up to 15 years)
- Effect of CPAP treatment on the incident cancers occurrence(during 6 months)