Ischemic Heart DiseaseEASY-PRIPCINCT04494750
Physiology and Residual Ischemia After Percutaneous Coronary Intervention
An observational study of Ischemic Heart Disease and Angina Pectoris, run by Laval University at 1 site in Canada.
Trial summary
Despite optimal angiographic result after stent implantation, a number of patients will undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational study evaluating the incidence of abnormal physiology results in patients undergoing repeat angiography after uncomplicated percutaneous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Angina Pectoris, Chest Pain
- How many people
- 260 participants
- Where
- 1 siteCanada
- Study dates
- 18 Feb 2021to Dec 2023
- 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 returning to the Quebec Heart Institute for a diagnostic angiography and possible PCI within 12 months of a previous uncomplicated PCI with stent implantation.
Who may be able to join
- Any patient referred for diagnostic angiography and possible PCI within 12 months of uncomplicated PCI with stent implantation.
Who cannot join
- Unable to understand study design or objectives of study.
- Unable to sign informed consent.
- Evidence of in-stent restenosis or significant untreated coronary lesions (initial incomplete revascularization)
- Inability to comply with the study follow-up
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
IUCPQ - Laval Hospital
Québec, G1V 4G5
Olivier F Bertrand, MD PhD, 418 656 8711, olivier.bertrand@crhl.ulaval.ca
Olivier F Bertrand, MD PhD
About this study
Official title: Physiology and Residual Ischemia After Percutaneous Coronary Intervention (EArly Discharge After Transradial Stenting of CoronarY Arteries- EASY- PRIPCI)
Despite optimal angiographic result after stent implantation, a number of patients will undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational study evaluating the incidence of abnormal physiology results in patients undergoing repeat angiography after uncomplicated percutaneous intervention (PCI).
Read the detailed description
Despite successful PCI and complete revascularization, about 25% of patients will present with angina and/or positive exercise testing during follow-up. With recurring or persistent symptoms, a number of those patients will be referred for control angiography. This might create a significant burden for health systems as well as putting patients to undergo further interventions without clear demonstration of ischemia.
Assessing physiology and fractional flow reserve in particular after PCI could represent a further step to determine whether stent implantation and stenosis removal will be effective to relieve subjective and objective signs of ischemia.
Hypothesis:
Resting gradients such as whole cycle Pd/Pa and diastolic dPR and FFR will be abnormal (below ischemic threshold) in > 20% of cases despite optimal stent implantation and angiographic result.
The use of physiology assessment in previously intervened vessels in patients referred for persisting or recurring angina might help operators to decide upon further intervention.
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Chest Pain, Coronary Artery Disease, Coronary Restenosis
- Keywords
- Coronary Artery Disease, Fractional Flow Reserve (FFR), Coronary physiology, Repeat intervention, diastolic pressure ratio (dPR)
- Medical subject headings
- Myocardial Ischemia, Angina Pectoris, Chest Pain, Coronary Artery Disease, Coronary Restenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful uncomplicated PCI as per coronary physiology ratios
Record the minimal values reported for Pd/Pa, dPR and FFR ratios in the distal vessel after uncomplicated PCI and good angiographic result.Comparison between baseline (pre PCI) and final (post PCI) coronary physiology ratios .
Measured: Transprocedural, initial and final values
Secondary outcomes (4)
Incidence and types of further interventions or imaging techniques
Record the incidence by type of intervention and diagnostic or imaging techniques
Measured: Historical and immediately after the procedure, up to 36 months
Residual symptoms and quality of life after repeat angiography
Identify residual symptoms after intervention, and overall immediate quality of life.
Measured: up to 30 days
Rates of repeat interventions
on previously intervened lesions versus PCI on new lesions
Measured: Historical and immediately after the procedure
Incidence of successful distal positioning of pressurewire
Measured: Transprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start18 Feb 2021
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Quebec Heart Institute
- Responsible party
- Principal investigator, Olivier F. Bertrand, Laval University
- Investigators
- Olivier F. Bertrand, MD, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494750
- Sponsor's protocol ID
- EASY-PRIPCI
- Acronym
- EASY-PRIPCI
- Status last verified
- Jan 2022
- First submitted
- 27 Jul 2020
- Last updated
- 31 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology and Residual Ischemia After Percutaneous Coronary Intervention (EArly Discharge After Transradial Stenting of CoronarY Arteries- EASY- PRIPCI)
- ClinicalTrials.gov ID
- NCT04494750
- Acronym / sponsor ID
- EASY-PRIPCI / EASY-PRIPCI
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Chest Pain, Coronary Artery Disease, Coronary Restenosis
- Keywords
- Coronary Artery Disease, Fractional Flow Reserve (FFR), Coronary physiology, Repeat intervention, diastolic pressure ratio (dPR)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Quebec Heart Institute
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Jul 2020 (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.
Despite optimal angiographic result after stent implantation, a number of patients will undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational study evaluating the incidence of abnormal physiology results in patients undergoing repeat angiography after uncomplicated percutaneous intervention (PCI).
Detailed description
Despite successful PCI and complete revascularization, about 25% of patients will present with angina and/or positive exercise testing during follow-up. With recurring or persistent symptoms, a number of those patients will be referred for control angiography. This might create a significant burden for health systems as well as putting patients to undergo further interventions without clear demonstration of ischemia.
Assessing physiology and fractional flow reserve in particular after PCI could represent a further step to determine whether stent implantation and stenosis removal will be effective to relieve subjective and objective signs of ischemia.
Hypothesis:
Resting gradients such as whole cycle Pd/Pa and diastolic dPR and FFR will be abnormal (below ischemic threshold) in > 20% of cases despite optimal stent implantation and angiographic result.
The use of physiology assessment in previously intervened vessels in patients referred for persisting or recurring angina might help operators to decide upon further intervention.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients returning to the Quebec Heart Institute for a diagnostic angiography and possible PCI within 12 months of a previous uncomplicated PCI with stent implantation.
Key inclusion criteria (1 listed)
- Any patient referred for diagnostic angiography and possible PCI within 12 months of uncomplicated PCI with stent implantation.
Key exclusion criteria (4 listed)
- Unable to understand study design or objectives of study.
- Unable to sign informed consent.
- Evidence of in-stent restenosis or significant untreated coronary lesions (initial incomplete revascularization)
- Inability to comply with the study follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of successful uncomplicated PCI as per coronary physiology ratios
Time frame: Transprocedural, initial and final values
Record the minimal values reported for Pd/Pa, dPR and FFR ratios in the distal vessel after uncomplicated PCI and good angiographic result.Comparison between baseline (pre PCI) and final (post PCI) coronary physiology ratios .
4 secondary outcomes
Incidence and types of further interventions or imaging techniques
Time frame: Historical and immediately after the procedure, up to 36 months
Residual symptoms and quality of life after repeat angiography
Time frame: up to 30 days
Rates of repeat interventions
Time frame: Historical and immediately after the procedure
Incidence of successful distal positioning of pressurewire
Time frame: Transprocedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
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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.
Olivier F. Bertrand, MD, PhD principal investigator
Laval University
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 Ischemic Heart Disease and Angina Pectoris, run by Laval University at 1 site in Canada.
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 4 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 31 Jan 2022. 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 Canada. 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 Olivier F. Bertrand, MD, PhD (+14186568711 ext. 5947, olivier.bertrand@chul.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful uncomplicated PCI as per coronary physiology ratios (time frame: Transprocedural, initial and final values). 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 31 Jan 2022.