Physiology and Residual Ischemia After Percutaneous Coronary Intervention (EASY-PRIPCI)

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).

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Chest Pain; Angina Pectoris; Ischemic Heart Disease; Coronary Restenosis

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 Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

• Study Contact: Name: Olivier F. Bertrand, MD, PhD; Phone Number: 5947 +14186568711; Email: olivier.bertrand@chul.ulaval.ca

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Recruiting
    • IUCPQ - Laval Hospital
    • Principal Investigator: Tomas Cieza, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	Transprocedural, initial and final values

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and types of further interventions or imaging techniques	Record the incidence by type of intervention and diagnostic or imaging techniques	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.	up to 30 days
Rates of repeat interventions	on previously intervened lesions versus PCI on new lesions	Historical and immediately after the procedure
Incidence of successful distal positioning of pressurewire		Transprocedural

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Quebec Heart Institute
• Investigators: Principal Investigator: Olivier F. Bertrand, MD, PhD, Laval University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Coronary physiology; Fractional Flow Reserve (FFR); Repeat intervention; diastolic pressure ratio (dPR)
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Stenosis; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Chest Pain; Angina Pectoris; Coronary Restenosis
• Other Study ID Numbers: EASY-PRIPCI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No