Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment cardiac pet, coronary catheterization
Sponsor University of Cincinnati
Start date August 2010
End date June 2017
Trial size 68 participants
Trial identifier NCT01719016, 10-05-05-02

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
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.
cardiac pet, coronary catheterization Volcano therapeutics
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

Primary Outcomes

Measure
Quantification of relative contributions of large artery disease and microvascular disease
time frame: 2 years

Secondary Outcomes

Measure
Quantification of relative contributions of large artery disease and microvascular disease
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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

Additional Information

Official title Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics
Principal investigator Rupak K Banerjee, PhD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Cincinnati.