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Active Not RecruitingNCT01719016

Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
68 (actual)
Sponsor
University of Cincinnati · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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.

Detailed 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).

Conditions

Interventions

TypeNameDescription
PROCEDURECardiac PET, Coronary catheterizationPatients 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

Timeline

Start date
2010-08-01
Primary completion
2025-07-30
Completion
2025-07-30
First posted
2012-11-01
Last updated
2025-05-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01719016. Inclusion in this directory is not an endorsement.