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Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes (RIGHT-PCI)

U

University of Sao Paulo General Hospital

Status

Enrolling

Conditions

Coronary Artery Disease
Angina Pectoris

Treatments

Procedure: Percutaneous Coronary Intervention (PCI)

Study type

Observational

Funder types

Other

Identifiers

NCT06545448
70150723.8.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,875 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,875 participants in 1 patient group

Patients undergoing elective PCI
Description:
Patients undergoing elective PCI for chronic coronary syndrome in a tertiary hospital in a single center in Brazil between 2017-2020.
Treatment:
Procedure: Percutaneous Coronary Intervention (PCI)

Trial contacts and locations

1

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Central trial contact

Luis Henrique W Gowdak, MD, PhD; Sara DV Ziotti, MD

Data sourced from clinicaltrials.gov

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