Nozari Younes, Geraiely Babak, Alipasandi Kian, Jalali Arash, Omidi Negar, Aghajani Hassan, Hajizeinali Alimohammad, Alidoosti Mohammad, Pourhoseini Hamidreza, Salarifar Mojtaba, Amirzadegan Alireza, Nematipour Ebrahim, Nomali Mahin
Department of Interventional Cardiology, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran.
Department of Cardiology, School of Medicine, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran.
JMIR Res Protoc. 2019 Mar 1;8(3):e13161. doi: 10.2196/13161.
Patients with ST-segment elevation myocardial infarction (STEMI) experience major adverse cardiac events (MACEs) following primary percutaneous coronary intervention (PCI). Although the relationship between time to treatment (eg, door-to-balloon time, symptom onset-to-balloon time, and symptom onset-to-door time) and 1-month all-cause mortality was assessed previously, its relationship with in-hospital MACEs and the effect of some clinical characteristics on this relationship were not considered. Furthermore, previous studies that were conducted in developed countries with a different quality of care cannot be applied in Iran, as Iran is a developing country and the studies were not performed according to the 24/7 primary PCI service registry.
The objective of this study protocol is to determine the relationship between time to treatment and in-hospital MACEs.
This cross-sectional study will take place at the Tehran Heart Center (THC), which is affiliated with Tehran University of Medical Sciences (TUMS) in Tehran, Iran. Data related to patients with STEMI, who underwent primary PCI between March 2015 and March 2019, that have been prospectively recorded in the THC's 24/7 primary PCI service registry will be analyzed. The study outcome is the occurrence of in-hospital MACEs. Data analysis will be conducted using SPSS for Windows, version 16.0 (SPSS Inc). We will perform chi-square tests, independent-samples t tests, or the Mann-Whitney U test, as well as univariate and multivariate binary logistic regression with a significance level of less than .05 and 95% CI for odds ratios.
From March 2015 to September 2017, 1586 patients were included in the THC service registry, consecutively. We will conduct a retrospective analysis of this registry on patient entries between March 2015 and March 2019 and data will be analyzed and published by the end of 2019.
To our knowledge, this is the first observational study based on the 24/7 primary PCI service registry in Iran. The findings of this study may reveal current problems regarding time to treatment in STEMI management in the THC. Results from this study may help determine appropriate preventive strategies that need to be applied in order to reduce time-to-treatment delays and improve patients' outcomes following primary PCI in the setting of STEMI at the THC and similar clinical centers.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13161.
ST段抬高型心肌梗死(STEMI)患者在接受直接经皮冠状动脉介入治疗(PCI)后会发生主要不良心脏事件(MACE)。尽管之前评估了治疗时间(如门球时间、症状发作至球囊时间和症状发作至门时间)与1个月全因死亡率之间的关系,但未考虑其与院内MACE的关系以及一些临床特征对这种关系的影响。此外,在医疗质量不同的发达国家进行的先前研究不能应用于伊朗,因为伊朗是一个发展中国家,且这些研究并非根据每周7天、每天24小时的直接PCI服务登记进行。
本研究方案的目的是确定治疗时间与院内MACE之间的关系。
这项横断面研究将在伊朗德黑兰与德黑兰医科大学(TUMS)附属的德黑兰心脏中心(THC)进行。将分析2015年3月至2019年3月期间在THC的每周7天、每天24小时直接PCI服务登记中前瞻性记录的STEMI患者的数据。研究结果是院内MACE的发生情况。将使用SPSS for Windows 16.0版(SPSS公司)进行数据分析。我们将进行卡方检验、独立样本t检验或曼-惠特尼U检验,以及单因素和多因素二元逻辑回归,显著性水平小于0.05,比值比的95%置信区间。
从2015年3月至2017年9月,1586例患者连续纳入THC服务登记。我们将对该登记中2015年3月至2019年3月期间的患者记录进行回顾性分析,并将于2019年底对数据进行分析和发表。
据我们所知,这是伊朗第一项基于每周7天、每天24小时直接PCI服务登记的观察性研究。本研究结果可能揭示THC在STEMI管理中目前治疗时间方面存在的问题。本研究结果可能有助于确定需要应用的适当预防策略,以减少治疗时间延迟,并改善THC及类似临床中心在STEMI情况下直接PCI后患者的预后。
国际注册报告识别码(IRRID):DERR1-10.2196/13161。