RECRUITING

Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Traditionally, the severity of a blockage (stenosis) in a coronary artery has been determined by visual angiographic assessment of the diameter of the artery at the level of a blockage compared to a normal healthy area of the same artery. With the advent of invasive physiological testing to assess coronary blood flow, multiple clinical trials have demonstrated a clinical benefit to a physiology-guided percutaneous coronary intervention (PCI) approach. However, despite this and the potential for significant variation in the interpretation of coronary artery stenosis severity by visual angiography alone to guide PCI, invasive physiologic indices remain significantly under-utilized. The purpose of this study is to investigate the physiologic significance of coronary lesions deemed angiographically severe by visual estimation that are planned for PCI. The investigators plan to perform blinded physiologic assessment pre and post PCI. The primary aim of the study is to determine whether a subset of lesions visually estimated as severe by angiography treated with stent placement/PCI may in fact not be physiologically significant when assessed invasively, and thus PCI could safely be deferred in these patients. A secondary aim is to evaluate physiologic assessment post PCI to detect residual ischemia that could be utilized to optimize stent placement.

Official Title

Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)

Quick Facts

Study Start:2022-10-11
Study Completion:2024-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05491668

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>/= 18 years
  2. * Patient provides written informed consent
  3. * Clinical presentation with stable coronary artery disease or acute coronary syndromes (unstable angina, Non-ST Elevation Myocardial Infarction (NSTEMI), or ST Elevation Myocardial Infarction (STEMI))
  4. * Scheduled for clinically indicated cardiac catheterization
  5. * At least one lesion with angiographic severity visually estimated to be \>/= 70% diameter stenosis that is deemed suitable for PCI
  6. * The operator plans to perform PCI on an ad hoc or planned basis
  7. * The target lesion is not planned for assessment by invasive physiology
  1. * Failure to provide signed informed consent
  2. * Culprit vessel of acute ST Elevation Myocardial Infarction (STEMI)
  3. * Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)
  4. * Thrombolysis In Myocardial Infarction (TIMI) flow less than grade 3 at baseline or visible thrombus
  5. * Chronic total occlusion (CTO) in the target vessel
  6. * Target vessel is supplied by major collaterals or supplies major collaterals to a CTO
  7. * Target lesion involves the left main coronary artery
  8. * Prior history of coronary artery bypass grafting (CABG) to the target vessel, except if bypass graft is occluded
  9. * Previously known untreated severe valvular heart disease
  10. * Previously known left ventricular ejection fraction \<30%
  11. * Sustained ventricular arrhythmias
  12. * Patients who are currently pregnant (pregnancy testing will be performed as per standard cardiac catheterization laboratory protocol)

Contacts and Locations

Study Contact

Eric Osborn, MD, PhD
CONTACT
617-632-7452
eosborn@bidmc.harvard.edu
Killian McCarthy, MB, BCh, BAO
CONTACT
617-632-0544
kmccar10@bidmc.harvard.edu

Principal Investigator

Eric Osborn, MD, PhD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Eric Osborn, MD, PhD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-11
Study Completion Date2024-10

Study Record Updates

Study Start Date2022-10-11
Study Completion Date2024-10

Terms related to this study

Keywords Provided by Researchers

  • Invasive physiology
  • Angiography
  • Percutaneous coronary intervention

Additional Relevant MeSH Terms

  • Coronary Artery Disease