Physiology and Residual Ischemia After Percutaneous Coronary Intervention

NCT04494750 | Unknown

• 1 other identifier: EASY-PRIPCI
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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).

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence and types of further interventions or imaging techniques

  Historical and immediately after the procedure, up to 36 months

• Residual symptoms and quality of life after repeat angiography

  up to 30 days

• Rates of repeat interventions

  Historical and immediately after the procedure

• Incidence of successful distal positioning of pressurewire

  Transprocedural

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Quebec Heart Institute: collaborator

Study Sites (1)

IUCPQ - Laval Hospital

Québec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Angina Pectoris; Chest Pain; Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Stenosis

Study Officials

• Olivier F. Bertrand, MD, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier F. Bertrand, MD, PhD

CONTACT

+14186568711; olivier.bertrand@chul.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the International Chair of Interventional Cardiology and Transradial Approach

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 31, 2020
• Study Start: February 18, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

CA (1)