Clinical trial NCT04494750: Physiology and Residual Ischemia After Percutaneous Coronary Intervention
Official title: Physiology and Residual Ischemia After Percutaneous Coronary Intervention (EArly Discharge After Transradial Stenting of CoronarY Arteries- EASY- PRIPCI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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)
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Quebec Heart Institute
First posted: 2020-07-31
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Any patient referred for diagnostic angiography and possible PCI within 12 months of uncomplicated PCI with stent implantation.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of successful uncomplicated PCI as per coronary physiology ratios
timeFrame: Transprocedural, initial and final values
Secondary outcomes:
measure: Incidence and types of further interventions or imaging techniques
timeFrame: Historical and immediately after the procedure, up to 36 months
measure: Residual symptoms and quality of life after repeat angiography
timeFrame: up to 30 days
measure: Rates of repeat interventions
timeFrame: Historical and immediately after the procedure
measure: Incidence of successful distal positioning of pressurewire
timeFrame: Transprocedural
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ - Laval Hospital
Study officials:
affiliation: Laval University
name: Olivier F. Bertrand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: