Actively Recruiting
Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes in a Cardiology Reference Hospital - The RIGHT-PCI Study
Led by University of Sao Paulo General Hospital · Updated on 2024-08-09
1875
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo General Hospital
Lead Sponsor
C
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how appropriate elective percutaneous coronary intervention (PCI), a procedure to open blocked heart arteries, is for patients with chronic coronary syndrome (CCS) who have symptoms not relieved by optimized medical treatment. This observational study focuses on measuring how often PCI is classified as appropriate, possibly appropriate, or rarely appropriate based on established criteria updated by the American College of Cardiology Foundation. The study addresses the gap in data about PCI use in Brazil compared to established studies in the United States and Japan. The study analyzes approximately 2,500 consecutive elective PCI procedures performed between 2017 and 2020 at a cardiology reference university hospital in Brazil. The PCI procedure is minimally invasive and is performed in patients with CCS symptoms under non-acute conditions after evaluation by a Heart Team. This study does not involve treatment assignment but observes clinical practice and PCI indication appropriateness. Participants are patients who underwent elective PCI, with data collected immediately after the procedure to classify PCI appropriateness. Researchers will also monitor outcomes such as mortality, non-fatal cardiovascular events, recurrent angina, and heart failure up to 12 months after the procedure. The study aims to provide insights into the quality of cardiovascular care and guide future treatment decisions for CCS patients in Brazil.
CONDITIONS
Brief Title
Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients who underwent elective PCI defined as a procedure planned in an outpatient or non-acute inpatient setting
- Patients whose PCI indication was agreed upon by a Heart Team
You will not qualify if you...
- History of acute coronary syndrome within 30 days before referral for PCI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo elective percutaneous coronary intervention (PCI) to treat chronic coronary syndrome.
1 procedure visit
Duration - 12 months
Participants are monitored for safety and outcomes including mortality, cardiovascular events, and symptoms for 12 months after PCI.
Approximately 3 to 4 follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Heart Institute (InCor-HCFMUSP)
São Paulo, São Paulo, Brazil, 05403000
Actively Recruiting
Research Team
L
Luis Henrique W Gowdak, MD, PhD
S
Sara DV Ziotti, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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