Kuwait Heart Foundation Registry of Acute Coronary Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,812
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Acute coronary syndrome (ACS) is the most common presentation of Coronary Artery Disease (CAD). It causes significant morbidity and mortality. The Gulf Registry of Acute Coronary Events (Gulf RACE) was conducted in 2007 and filled a wide gap in our understanding of ACS and its management in Kuwait and the Arabian Gulf region. However, the management of ACS has undergone tremendous advances over the last two decades involving pharmacotherapy and device therapy. Practice guidelines have also changed over the last decade. For example, in 2007, there was no catheterization laboratory in any of the general hospitals in Kuwait, primary percutaneous coronary intervention (PCI) was not being practiced, and the rate of in-hospital cardiac catheterization for all ACS patients was very low at around 10%. Currently, of the eight general hospitals in Kuwait, six have catheterization laboratories and five of the six serve as primary PCI centers. There is no contemporary ACS registry in Kuwait, studying its incidence, management, and influence of current changes in clinical practice on patients' outcomes. This multicentre disease-based, country-wide registry is guided by the American Heart Association policy statement for expanding the applications of existing and future clinical registries and the User's Guide published by the Agency for Health care Research and Quality guidance.
详细描述
This is a prospective, multicentre, country-wide registry of patients who are admitted to any of the eight general hospitals in Kuwait with a diagnosis of ACS over 6-months or more to include 10,000 patients. ACS diagnosis includes ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina.
The protocol mandates the following basic points:
- Enrol all consecutive patients who get admitted to hospital.
- Patients or their relatives should consent for enrolment in the registry.
- Follow-up of all patients for 30 days from the admission event.
The Principal Investigator has formed a steering committee and drafted a protocol and case report form (CRF). The steering committee members will meet to finalize the protocol and the CRF. Then an investigators meeting will be held to go over the fine details of the protocol and CRF and to instruct the investigators on how to use the online CRFs.
Data entry will be entered online. Quality Control Surveyors will carry out quality control visits. This will involve the inspection of 5% of the data source (hospital files) of enrolled patients against entered patient data for their accuracy. Centres that are identified to be consistently inaccurate will be warned and might be withdrawn from the registry if necessary. This quality control process will be carried out at 1 month and again at 3 months, from the start of the study. It will later be decided whether other subsequent checks would be required. In addition, the Chief Site Officer (CSO) in each hospital will be required to carry out quality control checks at his/her own hospital. This will involve the random checking of 2 files per week involving checking the online CRF and data source.
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
- •Patient is admitted to hospital with admission diagnosis of ACS.
- •Patient or a relative consent to enrolment in the registry.
排除标准
- •1- Refusal or inability to consent for enrolment
结局指标
主要结局
Mortality
时间窗: through study completion, an average of 6 months
To measure the adverse outcome of in-hospital mortality in ACS patients in Kuwait.
Major Adverse Cardiac Events (MACE)
时间窗: through study completion, an average of 6 months
To measure the in-hospital adverse outcomes like myocardial infarction (MI), cerebrovascular accident (CVA), bleeding, cardiogenic shock, heart failure and others in ACS patients in Kuwait.
次要结局
- Mortality(30 days from discharge)
- Major Adverse Cardiac Events (MACE)(30 days from discharge)
- Rehospitalization(within 30 days from discharge)
- Revascularization(within 30 days from discharge)
- Lipid level control(At 6 months from ACS event)
- Efficacy of lipid lowering agents(At 6 months from ACS event)
研究者
Mohammad Zubaid
Professor
Gulf Heart Association