Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

Study Overview
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Brief Summary
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Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with pressure and flow readings, are being investigated.

Detailed Description
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Diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. In order to achieve this, two novel parameters, pressure drop coefficient (CDP), which combines flow and pressure readings and Lesion flow coefficient (LFC), which combines anatomical details of the lesion with pressure and flow readings, are being investigated. The diagnostic parameters will be correlated with Coronary Flow Reserve (CFR)values obtained using Positron Emission Tomography (PET) imaging. They will also be correlated with Fractional Flow Reserve (FFR).

Official Title
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Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Cardiac PET, Coronary catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or above Patients referred to a stress test by a Cardiologist Acute Chest pain, as per patient input. Risk Assessment with prior test results and/or previous history of known chronic stable CAD. Borderline or discordant stress testing where obstructive CAD remains a concern. New or worsening symptoms- Abnormal coronary angiography or abnormal prior stress imaging study. Coronary stenosis or anatomic abnormality of uncertain significance. In absence of reliable diagnostic information from another imaging modality. Exclusion Criteria: Left ventricular ejection fraction less the 25% determined by gated SPECT imaging Non-dialysis dependent chronic kidney disease with baseline serum creatinine greater than 2.5 gm/dL. History of type II heparin-induced thrombocytopenia. Significant co-morbid condition that is medically unstable and would make coronary angiography prohibitive or contraindicated. Pregnant women. Incapacitated for Consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac PET, Coronary catheterization<br>Cardiac PET scan: Injection of N-13 Ammonia radionuclide. 2 doses of 10 milliCuries and 20 milliCuries each. Injection of Lexiscan. Coronary catheterization: Pressure and flow readings using Combowire Injection of Adenosine. | Procedure: Cardiac PET, Coronary catheterization<br>* Patients would under go a Cardiac rest and stress PET scan and include the following drug administration: N-13 Ammonia radionuclide - Two doses, 10 mCi for rest, 20 mCi for stress Lexiscan - stress agent for PET scan Patients would also undergo Coronary catheterization including the following drug administration and device usage: Combowire to obtain pressure and flow readings on Combomap machine (Volcano Therapeutics, CA). Adenosine - stress agent during catheterization, 140 ug/Kg/min<br>* Other names: N-13 Ammonia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of relative contributions of large artery disease and microvascular disease | Correlation Coronary Flow Reserve (CFR) from Positron Emission Tomography (PET)imaging with diagnostic parameters, Pressure Drop Coefficient (CDP) and Lesion Flow Coefficient (LFC). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of relative contributions of large artery disease and microvascular disease | Correlation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reversible ischemia, microvascular dysfunction