冠状动脉支架试验中的临床终点:为标准化定义提供了一个案例
Donald E Cutlip1, Stephan Windecker, Roxana Mehran
1Harvard Clinical Research Institute, Harvard Medical School, 930 Commonwealth Avenue, Boston, MA 02215, USA. dcutlip@bidmc.harvard.edu
Circulation
|May 2, 2007
概括
冠状动脉支架试验的标准化定义对于一致的安全性和有效性评估至关重要. 学术研究联盟为像支架血栓瘤这样的关键终点制定了共识标准.
科学领域:
- 心血管研究的心血管研究.
- 医疗器械试验 医疗器械试验
- 干预性心脏病学 干预性心脏病学
背景情况:
- 冠状动脉支架的临床试验经常使用非统一的安全性和有效性终点定义.
- 这种缺乏标准化的情况在解释试验结果时造成了混乱.
- 为了准确的比较和监管审查,需要一致的终点定义.
研究的目的:
- 建立药物释放支架评估中的临床终点的共识定义.
- 为在临床试验中提供一致的终点评估提供建议.
主要方法:
- 召开了学术研究联盟 (ARC) 与监管机构 (美国FDA) 和设备制造商的会议.
- 制定了评估死亡,心肌梗塞,重复血管化和支架血栓形成的共识标准.
- 在标准开发中考虑历史数据,病理生理学和临床解释性.
主要成果:
- 为冠状动脉支架试验中的关键临床终点建立了广泛的共识定义.
- 建议涵盖主要心脏不良事件和设备特定并发症的评估.
- 开发的标准旨在提高药物释放支架评估的一致性.
结论:
- 共识标准提高了评估冠状动脉支架安全性和有效性的研究的一致性.
- 标准化的终点有助于对临床试验数据进行更可靠的解释.
- 这些标准对于干预性心脏病学的监管和临床试验目的是有价值的.
相关概念视频
Assessment of blood pressure in brachial artery(one-step method)
This procedural guide systematically measures blood pressure using an oscillometric digital sphygmomanometer, emphasizing accuracy, patient safety, and comfort.
Prepare for the Procedure:
Prepare for the Procedure:
Assessment of blood pressure in brachial artery(two-step method)
Measuring blood pressure is a fundamental skill in healthcare that aids in diagnosing and monitoring hypertension and other cardiovascular conditions. An aneroid sphygmomanometer, commonly used in clinical settings, offers a manual and precise method for blood pressure measurement. The technique for using this instrument involves specific steps that must be carefully executed to ensure accuracy. The following detailed description outlines a two-step technique for assessing blood pressure using...
Pre-Procedural Guidelines for Assessing Blood Pressure
Accurate blood pressure assessment is crucial for diagnosing and managing various health conditions. To ensure the reliability of these measurements, healthcare professionals must adhere to standardized pre-procedural guidelines. These guidelines enhance patient safety and improve the overall quality of healthcare. The following steps are essential for obtaining accurate and consistent blood pressure readings, from using the appropriate tools to ensuring effective communication with the patient.
Aortic Regurgitation II: Clinical Features and Diagnostic Tests
Aortic valve regurgitation (AR) occurs when the aortic valve fails to close properly, allowing blood to flow backward from the aorta into the left ventricle. This backflow can result in two distinct clinical presentations: acute and chronic AR, each characterized by its own set of symptoms and physical findings.Acute Aortic RegurgitationAcute AR presents with a sudden onset of severe symptoms. Patients typically experience profound dyspnea (shortness of breath), chest pain, and signs of left...
Acute Coronary Syndrome III: Diagnostic Studies
Diagnosing acute coronary syndrome or ACS begins with a thorough patient history. Notable symptoms include central, crushing chest pain radiating to the left arm, neck, jaw, or back, along with shortness of breath, sweating (diaphoresis), nausea, vomiting, dizziness, and palpitations.It is crucial to note any history of cardiac illnesses and assess risk factors, including age, gender, smoking, hypertension, diabetes, hyperlipidemia, and a sedentary lifestyle.During physical examination, vital...
Peripheral Arterial Disease II: Clinical Manifestations and Diagnostic Evaluation
Clinical manifestationsPeripheral Arterial Disease (PAD) manifests through a range of symptoms, from the characteristic intermittent claudication to atypical presentations and severe complications in advanced stages. Intermittent claudication, a hallmark symptom of PAD, presents as exercise-induced muscle pain that typically resolves within minutes of rest. This pain is reproducible and stems from inadequate blood flow, leading to the accumulation of lactic acid produced during anaerobic...


