跳至主要内容
临床试验/NCT02090712
NCT02090712Enrolling By Invitation不适用

Reperfusion Strategies in ST Elevation Myocardial Infarction Network - Sao Paulo Registry.

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
3,000
试验地点
1
主要终点
Binary MACCE

研究概览

简要总结

At the periphery of the city of São Paulo, in-hospital mortality in acute myocardial infarction is estimated to range between 15% and 20% due to difficulties inherent to delayed answer at a large metropolis. As a city with more than 11 million inhabitants, the distribution of emergency services and public hospitals is also heterogeneous, with scarcity in peripheral zones. That heterogeneity of resources also involves the quality of the medical care provided. The possibility of a standard care with fast transfer after thrombolysis and a tertiary backing system for ECG interpretation, catheterization and advanced support could improve this setting.

In a project initiated in 2010, the São Paulo Municipal Health Secretariat, the Federal University of Sao Paulo/Paulista School of Medicine, the Emergency Mobile Health Care Service arranged a planed system of thrombolysis at peripheral hospitals or at the ambulances with immediate transfer to a unique tertiary center for early angiography and angioplasty of the culprit artery. The protocol uses recommendations of Brazilian and international guidelines, and is the same adopted for the management of ST elevation myocardial infarction at Paulista School of Medicine regarding the indications for thrombolytic agents, primary and rescue percutaneous transluminal coronary angioplasty (PTCA), and pharmacoinvasive therapy.

The hypothesis of this study is that a network to provide the best care for patients with ST elevation myocardial infarction will reduce mortality rates.

The main purpose of this registry is to provide demographics, metrics and results of this experience, maintaining complete records of clinical, laboratory and coronary angiography data of all patients allowing short-term outcome analysis of various variables in a large population. Additionally, follow-up outcomes will be provide in a sub-group of patients keeping their health care at the University or able to be tracked.

All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation at different time intervals.

详细描述

Reperfusion Strategies in ST Elevation Myocardial Infarction Network - Sao Paulo Registry.

Preparation and implementation of the ST segment elevation myocardial network in Sao Paulo:

Initially, in 2009 a 24-hour central office for electrocardiogram (ECG) reading was installed at Hospital São Paulo - Paulista School of Medicine to receive EKG's sent from 126 SAMU ambulances, covering the entire São Paulo city area. The ECGs were transmitted to the central office via mobile phone, fixed phone or Internet, and immediately interpreted by a team of cardiologists, by using guidelines for STEMI ECG diagnosis. The EKG reports were sent back to the mobile phone of the transmitting ambulance. With this system in place and working adequately, the Municipal Health Secretariat of São Paulo made the fibrinolytic agent tenecteplase (TNK) available initially in four municipal emergency rooms (ER) of large peripheral hospitals, with a previous history of receiving a large number of patients with AMI (Ermelino Matarazzo ER, Campo Limpo ER, Tatuapé ER, and Saboya ER). The medical and nursing teams of these hospitals were trained and updated on the clinical diagnosis of acute coronary syndromes, ECG recognition of STEMI, and indications of thrombolytic agents and primary PTCA in STEMI. A direct and immediate contact, via an exclusive mobile phone line, was established between the advanced ambulances or the ERs and the Coronary Unit of Hospital São Paulo. Thus, a patient diagnosed with STEMI, who was at an ER or in an ambulance and could be in a catheterization laboratory in less than 90 minutes or with contra-indication to thrombolysis was referred for primary PTCA. If the advanced ambulance was very far away or if the estimated travel time for a patient at one of the ERs was longer than 90 minutes, he/she would receive TNK; after thrombolysis, the patient would be immediately transferred to Sao Paulo Hospital, and would undergo either rescue PTCA, if necessary, or cardiac catheterization within 6 to 24 hours, if clinically stable. The dose of TNK ranged from 30 mg to 50 mg, meeting the known criteria for indication and contraindication of fibrinolytic drugs. In addition to TNK, the patients received as adjuvant therapy and according to the Brazilian and international guidelines the recommended doses of morphine, low molecular weight heparin (properly corrected to weight and renal function), IV nitrates and oral medications, such as, aspirin, clopidogrel, statins and beta-blockers.

An expansion of the primary network was made in 2011 to allow 3 more ER's to be included in the network (Pirituba, Joao XXIII, Servidor Municipal) and one more in 2013 (Vila Maria), summing up at the moment 8 fixed ER units plus SAMU ambulances.

After catheterization, patients are maintained in the tertiary hospital if they are in advanced Killip class or have left main or severe LV dysfunction and were referred back to the primary center 24 hours after cath or PCI if stable, with good LV function and 1 or 2 vessel disease.

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

入选标准

  • Patients with acute ST segment elevation myocardial infarction diagnosed by the presence of typical symptoms and electrocardiogram (ECG) alterations (either ST segment elevation or presumable new left bundle branch block) within the first 12 hours of symptoms able to receive thrombolysis with tenecteplase (TNK) or to be transferred for primary angioplasty in a tertiary center.

排除标准

  • Age under 18 years-old
  • Contra-indication to tenecteplase or any antiplatelet or anticoagulant therapy (mainly due to the presence of factors predisposing to bleeding events).

结局指标

主要结局

Binary MACCE

时间窗: 30 days

All cause death, cerebrovascular event (stroke), documented myocardial infarction, major bleeding, repeat revascularization (PCI or surgery).

次要结局

  • Major Bleeding(30 days)
  • MACCE at 1 year(1 YEAR)
  • Individual end-points of MACCE(1 year)
  • Congestive Heart Failure (CHF)(30 days)
  • MACCE at 5 years(5 years)
  • Individual end-points of MACCE 5 years(5 years)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iran Gonçalves Junior, MD, PhD

Assistant professor - Department of Cardiology

Federal University of São Paulo

研究点 (1)

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