Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

N/AActive Not RecruitingNCT01719016

University of Cincinnati68 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease

Interventions

Cardiac PET, Coronary catheterizationPROCEDURE

Patients would under go a Cardiac rest and stress PET scan and include the following drug administration: 1. N-13 Ammonia radionuclide - Two doses, 10 mCi for rest, 20 mCi for stress 2. Lexiscan - stress agent for PET scan Patients would also undergo Coronary catheterization including the following drug administration and device usage: 1. Combowire to obtain pressure and flow readings on Combomap machine (Volcano Therapeutics, CA). 2. Adenosine - stress agent during catheterization, 140 ug/Kg/min

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Cincinnati Veteran Affairs Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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).

Time frame: 2 years

Secondary Outcomes

Quantification of relative contributions of large artery disease and microvascular disease

Correlation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values.

Time frame: 2 years

Data from ClinicalTrials.gov

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