the PrEsentation, Rationale and Impact of reperFUSION for Acute Coronary Syndromes in Cape Town and the Garden Route Health District - the PERFUSION Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 870
- 试验地点
- 4
- 主要终点
- 1-year combined primary endpoint
研究概览
简要总结
The global burden and threat of non-communicable diseases (NCDs) have become a major health challenge that undermines social and economic development throughout the world. Cardiovascular disease including acute coronary syndromes (ACS) currently accounts for 17.9 million deaths a year. Low and middle-income countries such as those in sub-Saharan Africa (SSA) have undergone a rapid epidemiological transition over the last few decades and now have a burden of disease increasingly dominated by NCDs. The global burden of disease report for 2017 revealed a 71.4% increase in cardiovascular disease in SSA, predicting a large increase in mortality. Unfortunately, reliable population-level data regarding the incidence, prevalence and demographics of ACS in SSA are limited. The investigators propose to set up and conduct a multi-centre, prospective, observational registry to describe the demographics, clinical characteristics, presentation, management and outcomes of patients admitted with ACS in Cape Town and the Garden Route Health District, Western Cape Province, South Africa. The registry is designed to shed insight on the current burden and impact of atherosclerotic cardiovascular disease in the Western Cape.
详细描述
The investigators propose to set up and conduct a multi-centre, prospective, observational registry to describe the demographics, clinical characteristics, presentation, management and outcomes of patients admitted with ACS in Cape Town and the Garden Route Health District, Western Cape Province, South Africa.
The aims of this prospective multi-centre registry are to describe the burden, demographics, risk factor profile, clinical course, management, and outcomes of patients presenting with ACS across the Cape Town metropole and the Garden Route Health District. The registry will be called "the PrEsentation, Rationale and impact of reperFUSION for Acute Coronary Syndromes in Cape Town - the PERFUSION registry". It will be designed to determine the feasibility of conducting a large multi-centre Acute Coronary Syndrome registry in South Africa.
Primary Objectives:
- to enrol consecutive patients presenting with acute coronary syndromes from designated participating sites;
- to describe the demographic and risk factor profile of participants with ACS;
- to describe the burden of patients presenting with ACS in the Cape Town metropole and the Garden Route Health District;
- to describe the management of patients with ACS and assess compliance with current South African guidelines;
- to describe the one month, six-month and 12-month outcomes with regard to all-cause mortality, hospitalisation, and major adverse cardiac events (recurrence of ACS, heart failure, stroke and ventricular tachy-arrythmias).
Methods:
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
- •signed written informed consent before any study recruitment; and
- •male or female patients age ≥ 18 years of age; and
- •a diagnosis of ACS (STEMI, NSTEMI or UA).
排除标准
- •ACS absent within index admission; or
- •refusal of consent
结局指标
主要结局
1-year combined primary endpoint
时间窗: 1 year
all-cause death, cardiac death, re-hospitalisation myocardial infarction, cerebrovascular accident
次要结局
- 6 month combined end point(6-month)
- 1 month combined end point(1-month)
- cardiac adverse events(1-year)
- Compliance profile(1-year)
- Refusion time(1-year)
研究者
Kishal Lukhna
Dr
University of Cape Town