Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >/= 18 years
Patient provides written informed consent
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))
Scheduled for clinically indicated cardiac catheterization
Disqualifiers
Failure to provide signed informed consent
Culprit vessel of acute ST Elevation Myocardial Infarction (STEMI)
Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)
Thrombolysis In Myocardial Infarction (TIMI) flow less than grade 3 at baseline or visible thrombus
Trial population
Study population will consist of male and female subjects from the general interventional cardiology population who are scheduled for coronary angiogram at Beth Israel Deaconess Medical Center
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-hyperemic pressure ratio assessment pre and post PCI
Diagnostic testPre and post PCI invasive physiologic assessment
Treatment groups
107 Participants
are divided into 1 treatment groupGroup A: Coronary Physiology Assessment1 intervention
Trial outcomes
Primary outcomes
1
The percentage of physiologically non-significant lesions observed
Non-significant lesions defined as a diastolic pressure ratio (dPR) \</= 0.89 (range 0-1), expressed as mean, standard deviation, and percentage of total number of assessments
Time frame
Time of procedure2
Correlation of the operator visual angiographic assessment of stenosis severity with quantitative coronary angiography (QCA) and resting non-hyperemic pressure resting indices (NHPR)
Visual stenosis severity and QCA are numerical variables reported as percentages, and expressed as mean and standard deviation. NHPR is a numerical variable from 0 to 1, expressed as mean and standard deviation. Pearson correlation coefficient used to express correlation between two variables.
Time frame
Within 30 days post procedure3
Correlation between QCA and NHPR
QCA is a numerical variable reported as a percentage, and expressed as mean and standard deviation. NHPR is a numerical variable from 0 to 1, expressed as mean and standard deviation. Pearson correlation coefficient used to express correlation between two variables.
Time frame
Within 30 days post procedureSecondary outcomes
1
Correlation of the post-PCI NHPR with burden of angina as assessed via the Seattle Angina Questionnaire at 30 days post PCI
NHPR is a numerical variable from 0 to 1, expressed as mean and standard deviation. Seattle Angina Questionnaire assesses patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, expressed as mean and standard deviation. Pearson correlation coefficient used to express correlation between two variables.
Time frame
Day 30 post PCI2
Change in angina as assessed via the Seattle Angina Questionnaire at baseline and 30 days after PCI, need for titration for anti-anginal medications, or need for repeat coronary angiography within 30 days of the procedure.
Seattle Angina Questionnaire assesses patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, expressed as mean and standard deviation. Comparison of baseline and 30 days post PCI involves comparison of numerical variables and uses the Student's paired t test or Wilcoxon signed rank test. Need for titration for anti-anginal medications and need for repeat coronary angiography within 30 days of the procedure are descriptive data (Yes, No)
Time frame
Day 30 post PCISponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
Opsens, Inc.
Collaborator
Source ClinicalTrials.gov