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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Angina Pectoris
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention (PCI)

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.

• Study Type: Observational
• Enrollment (Estimated): 1875

Contacts and Locations

• Study Contact: Name: Luis Henrique W Gowdak, MD, PhD; Phone Number: 551126614326; Email: luis.gowdak@incor.usp.br
• Study Contact Backup: Name: Sara DV Ziotti, MD; Phone Number: 551126614326; Email: sara.ziotti@usp.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403000
      • Recruiting
      • Heart Institute (InCor-HCFMUSP)
      • Contact: Luis Henrique W Gowdak, MD, PhD; Phone Number: 551126614326; Email: luis.gowdak@incor.usp.br
      • Contact: Sara DV Ziotti, MD; Phone Number: 551126614326; Email: sara.ziotti@usp.br
      • Principal Investigator: Sara DV Ziotti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients within the age range who underwent elective PCI indicated their own physicians. This procedure was defined as 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing elective PCI; Patients undergoing elective PCI for chronic coronary syndrome in a tertiary hospital in a single center in Brazil between 2017-2020.	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.; Other Names: Angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the rates of elective PCI classified as appropriate, possibly appropriate, or rarely appropriate.	Determine the rates of elective PCI classified as appropriate, possibly appropriate, or rarely appropriate based on the Appropriateness Criteria proposed by the ACC / AHA in 2017.	Immediately following the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, periprocedural stroke, or the need for new revascularization)	Incidence of the composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction based on the 4th Universal Definition of MI, periprocedural stroke occurring during the hospitalization index, or the need for new revascularization either by CABG or PCI)	12 months after the procedure index
Incidence of persistent or recurrent post-PCI angina or new onset/worsening heart failure	Incidence of persistent or recurrent post-PCI angina or new onset/worsening heart failure both clinically manifest	12 months after the procedure index

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and sociodemographic predictors of rarely appropriate elective PCI	Clinical and sociodemographic predictors of rarely appropriate elective PCI	Immediately following the procedure

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 12, 2020
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Treatment; Prognosis; Coronary artery disease; Angioplasty; Angina pectoris; Appropriateness
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris
• Other Study ID Numbers: 70150723.8.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is no formal plan yet, but our team will consider any suggestions for a joint study.
• IPD Sharing Time Frame: 5 years from the first publication
• IPD Sharing Access Criteria: By e-mail only
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No