跳至主要内容
临床试验/NCT01932294
NCT01932294已完成不适用

Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support

National Heart, Lung, and Blood Institute (NHLBI)11 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
171
试验地点
11
主要终点
Number of Heart Failure Participants Deceased at 24 Months

研究概览

简要总结

Medamacs is a prospective, observational study of ambulatory patients with advanced heart failure. The study enrolls patients who have not yet received a Left Ventricular Assist Device (LVAD) but who receive their care at a hospital with a Joint Commission certified mechanical circulatory support program.

Medamacs is funded through the Interagency for Mechanically Assisted Circulatory Support (INTERMACS) NHLBI Contract.

详细描述

Participants between 18 and 80 years old with low ejection fraction history and hospitalization for heart failure within the past year will be screened for the study. All subjects who have been admitted to the heart failure service will be screened and recruited, either as an inpatient or during their first outpatient follow-up appointment by the investigator and research staff caring for patients in the advanced heart failure program.

Eligibility for enrollment will be based only upon information that is clinically available at the time of screening. The history of prior hospitalizations will be available from clinical records.

Routine evaluation and triage of ambulatory patients with advanced heart disease includes echocardiography and functional assessment with peak oxygen consumption and frequently 6 minute walk distance. The elements of information required for estimation of the Seattle Heart Failure Risk score will be gleaned from laboratory data, or imputed as described in the Seattle score literature. The research coordinator will enter this data onto a currently available website for calculation of the Seattle score.

Eligibility will be determined by the inclusion and exclusion criteria and the study research team will approach individual subjects who are potential candidates for participation once the subject's primary physician has given permission to approach. Only persons with a scientific or ethical reason will be excluded. Incarcerated prisoners have been excluded by this protocol.

Participants will be followed every 6 months for 24 months after two baseline visits. The 6 month and 18 month follow ups consist of telephone interviews. Follow ups at 12 months and 24 months consists of routine clinical visits.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Heart Failure Participants Deceased at 24 Months

时间窗: 6 month intervals after the baseline visit up to 24 months

Death after the baseline visit up to 24 months

次要结局

  • Number of Participants With Known Ventricular Assist Device (VAD) Implantation(6 month intervals after the baseline visit up to 24 months)
  • Number of Participants With Known Heart Transplantation(6 month intervals after the baseline visit up to 24 months)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (11)

Loading locations...

相似试验