Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes

Официальное название

Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes in a Cardiology Reference Hospital - The RIGHT-PCI Study

Обзор

Percutaneous coronary intervention (PCI) has dramatically changed the treatment of obstructive coronary artery disease patients. PCI is indicated in patients with chronic coronary syndrome (CCS) symptoms unresponsive to optimized medical therapy. The American College of Cardiology Foundation and partners developed in 2009 - and updated them in May 2017 - the appropriateness criteria for PCI to support the rational use of PCI in chronic patients and to provide patients with high-quality cardiovascular care. Since then, these criteria have been applied to guide physicians and serve as metrics of the quality of care based on the best available scientific evidence. Countries like the United States and Japan already have robust studies on the topic with important repercussions on clinical practice. In Brazil, to date, there are no studies on the adequacy of PCIs in patients with CCS.

Подробное описание

Percutaneous coronary intervention (PCI) has dramatically changed the treatment of obstructive coronary artery disease patients. PCI is indicated in patients with chronic coronary syndrome (CCS) symptoms unresponsive to optimized medical therapy. The American College of Cardiology Foundation and partners developed in 2009 - and updated them in May 2017 - the appropriateness criteria for PCI to support the rational use of PCI in chronic patients and to provide patients with high-quality cardiovascular care. Since then, these criteria have been applied to guide physicians and serve as metrics of the quality of care based on the best available scientific evidence. Countries like the United States and Japan already have robust studies on the topic with important repercussions on clinical practice. In Brazil, to date, there are no studies on the adequacy of PCIs in patients with CCS.

The primary goal of the RIGHT-PCI study is to determine the rate of PCI indications categorized as appropriate, possibly appropriate, or rarely appropriate in patients with CCS undergoing elective PCI based on criteria established in medical literature at a Cardiology reference university hospital. To achieve this objective, we plan to analyze approximately 2,500 consecutive angioplasties performed between 2017 and 2020.

Вмешательства

• Процедура Percutaneous Coronary Intervention (PCI)
  A percutaneous coronary intervention (PCI) is a minimally invasive procedure to open blocked coronary (heart) arteries. An older name for PCI is coronary angioplasty with stenting or angioplasty for short.

Первичные конечные точки

• Determine the rates of elective PCI classified as appropriate, possibly appropriate, or rarely appropriate. [Срок оценки: Immediately following the procedure]

Вторичные конечные точки (2)

• Incidence of the composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, periprocedural stroke, or the need for new revascularization) [Срок оценки: 12 months after the procedure index]
• Incidence of persistent or recurrent post-PCI angina or new onset/worsening heart failure [Срок оценки: 12 months after the procedure index]

Критерии участия

Критерии включения

• All patients within the age range who underwent elective PCI defined as a procedure indicated in an outpatient scenario or an inpatient in a non-acute setting when the Heart Team was called to evaluate the patient and agreed with the indication for PCI

Критерии исключения

• History of acute coronary syndrome < 30 days of the referral for PCI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бразилия · 1 центр

• Heart Institute (InCor-HCFMUSP) — São Paulo

Идентификаторы

NCT: NCT06545448 · 70150723.8.0000.0068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗