Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percutaneous Coronary Intervention (PCI).
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Angina Pectoris. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes in a Cardiology Reference Hospital - The RIGHT-PCI Study
Overview
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.
Detailed description
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.
Interventions
- Procedure 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.
Primary outcome measures
- Determine the rates of elective PCI classified as appropriate, possibly appropriate, or rarely appropriate. [Time frame: Immediately following the procedure]
Secondary outcome measures (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) [Time frame: 12 months after the procedure index]
- Incidence of persistent or recurrent post-PCI angina or new onset/worsening heart failure [Time frame: 12 months after the procedure index]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- History of acute coronary syndrome < 30 days of the referral for PCI
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Heart Institute (InCor-HCFMUSP) — São Paulo
Identifiers
NCT: NCT06545448 · 70150723.8.0000.0068