Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of acute coronary syndrome < 30 days of the referral for PCI
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Percutaneous Coronary Intervention (PCI)
Procedure/SurgeryA 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.
Treatment groups
1,875 Participants
are divided into 1 treatment groupGroup A: Patients undergoing elective PCI1 intervention
Trial outcomes
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.
Time frame
Immediately following the procedureSecondary outcomes
1
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)
Time frame
12 months after the procedure index2
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
Time frame
12 months after the procedure indexOther outcomes
1
Clinical and sociodemographic predictors of rarely appropriate elective PCI
Clinical and sociodemographic predictors of rarely appropriate elective PCI
Time frame
Immediately following the procedureSponsors and contacts
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University of Sao Paulo General Hospital
Lead sponsor
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Collaborator
Source ClinicalTrials.gov