Coronary Artery DiseaseRIGHT-PCINCT06545448
Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes
An observational study of Coronary Artery Disease and Angina Pectoris, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris
- What is being tested?
- Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- 1,875 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2017to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- History of acute coronary syndrome < 30 days of the referral for PCI
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute (InCor-HCFMUSP)
São Paulo, São Paulo, 05403000
Luis Henrique W Gowdak, MD, PhD, 551126614326, luis.gowdak@incor.usp.br
Sara DV Ziotti, MD, 551126614326, sara.ziotti@usp.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Being tested
- Percutaneous Coronary Intervention (PCI)
- Keywords
- Coronary artery disease, Angina pectoris, Angioplasty, Appropriateness, Prognosis, Treatment
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (PCI)Procedure or surgery
Also called Angioplasty
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Percutaneous Coronary Intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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)
Measured: 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
Measured: 12 months after the procedure index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Dec 2017
- Primary completion12 Dec 2020
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,875 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545448
- Sponsor's protocol ID
- 70150723.8.0000.0068
- Acronym
- RIGHT-PCI
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is no formal plan yet, but our team will consider any suggestions for a joint study.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes in a Cardiology Reference Hospital - The RIGHT-PCI Study
- ClinicalTrials.gov ID
- NCT06545448
- Acronym / sponsor ID
- RIGHT-PCI / 70150723.8.0000.0068
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Keywords
- Coronary artery disease, Angina pectoris, Angioplasty, Appropriateness, Prognosis, Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,875 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 2,500 consecutive angioplasties performed between 2017 and 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing elective PCI | – | Procedure: Percutaneous Coronary Intervention (PCI)Patients undergoing elective PCI for chronic coronary syndrome in a tertiary hospital in a single center in Brazil between 2017-2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- History of acute coronary syndrome < 30 days of the referral for PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary Intervention (PCI)Also: AngioplastyA 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. | Procedure or surgery | Patients undergoing elective PCI |
Primary outcome
Determine the rates of elective PCI classified as appropriate, possibly appropriate, or rarely appropriate.
Time frame: Immediately following the procedure
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.
2 secondary outcomes
Incidence of the composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, periprocedural stroke, or the need for new revascularization)
Time frame: 12 months after the procedure index
Incidence of persistent or recurrent post-PCI angina or new onset/worsening heart failure
Time frame: 12 months after the procedure index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. There is no formal plan yet, but our team will consider any suggestions for a joint study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Angina Pectoris, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Henrique W Gowdak, MD, PhD (551126614326, luis.gowdak@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the rates of elective PCI classified as appropriate, possibly appropriate, or rarely appropriate. (time frame: Immediately following the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.