Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes

NCT06545448 | Recruiting

• 1 other identifier: 70150723.8.0000.0068
• Study Type: observational
• Target: 1,875
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Angina Pectoris

Keywords

Coronary artery disease; Angina pectoris; Angioplasty; Appropriateness; Prognosis; Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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)

  12 months after the procedure index

• Incidence of persistent or recurrent post-PCI angina or new onset/worsening heart failure

  12 months after the procedure index

Other Outcomes (1)

• Clinical and sociodemographic predictors of rarely appropriate elective PCI

  Immediately following the procedure

Study Arms (1)

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)

Interventions

Percutaneous Coronary Intervention (PCI) PROCEDURE

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.

Also known as: Angioplasty

Patients undergoing elective PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Heart Institute (InCor-HCFMUSP)

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris

Interventions

Percutaneous Coronary Intervention; Angioplasty

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Catheterization; Therapeutics; Investigative Techniques

Central Study Contacts

Luis Henrique W Gowdak, MD, PhD

CONTACT

551126614326; luis.gowdak@incor.usp.br

Sara DV Ziotti, MD

CONTACT

551126614326; sara.ziotti@usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: December 1, 2017
• Primary Completion: December 12, 2020
• Study Completion: December 31, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 5 years from the first publication
• Access Criteria: By e-mail only

Locations

BR (1)