Viewing Study NCT06545448



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06545448
Status: RECRUITING
Last Update Posted: None
First Post: 2024-08-05

Brief Title: Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes
Sponsor: None
Organization: None

Study Overview

Official Title: Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes in a Cardiology Reference Hospital - The RIGHT-PCI Study
Status: RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RIGHT-PCI
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
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 2500 consecutive angioplasties performed between 2017 and 2020

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None