Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2026-03-31

Brief Summary

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The purpose of this study is to assess whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events than standard angiographic guidance.

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Detailed Description

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Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximal flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR value less than or equal to 0.80 is generally considered to be associated with myocardial ischemia.

FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. this ratio represents the potential decrease in coronary flow distal o the coronary stenosis. Recently, other physiology ratios called non-hyperemic ratios (NHPR) have been developed.

Both types of physiology measures (FFR and NHPR) have been increasingly used in cardiac catheterization laboratories as a diagnostic tool. They provide a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization. However, they are underutilized as tools for the assessment of success of coronary interventions.

The PREDICT study is a pilot study which aims to prospectively determine whether post-PCI physiology guidance is associated with better clinical outcomes than standard angiographic guidance.

Conditions

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Coronary Artery Disease Stable Angina Unstable Angina Ischemic Heart Disease Chest Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Angiographical guidance only

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-PCI FFR guidance

Post-PCI Fractional Flow Reserve and non-hyperemic pressure ratios measurement

Group Type EXPERIMENTAL

post-PCI FFR

Intervention Type PROCEDURE

final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.

Interventions

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post-PCI FFR

final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.

Intervention Type PROCEDURE

Other Intervention Names

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Fractional Flow Reserve Non-hyperemic pressure ratios

Eligibility Criteria

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Inclusion Criteria

* Any patient referred for diagnostic coronary angiography and / or possible PCI in native coronary vessels.
* Successful (\< 30% diameter stenosis and normal TIMI 3 flow post-stenting) and uncomplicated PCI
* All treated lesions stented with drug-eluting stents (except side-branches of bifurcations)

Exclusion Criteria

* Lesion in saphenous vein or arterial grafts
* Allergy to aspirin, thienopyridines or ticagrelor precluding treatment for 30 days
* Sub-optimal PCI result ( \>30% residual diameter stenosis and/or \<TIMI3 flow) or peri-procedural complications
* Acute ST-Elevation MI (culprit lesion)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No