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Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01719016
Enrollment
68
Registered
2012-11-01
Start date
2010-08-01
Completion date
2027-07-30
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Reversible ischemia, microvascular dysfunction

Brief 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).

Interventions

PROCEDURECardiac PET, Coronary catheterization

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

Sponsors

University of Cincinnati
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quantification of relative contributions of large artery disease and microvascular disease2 yearsCorrelation Coronary Flow Reserve (CFR) from Positron Emission Tomography (PET)imaging with diagnostic parameters, Pressure Drop Coefficient (CDP) and Lesion Flow Coefficient (LFC).

Secondary

MeasureTime frameDescription
Quantification of relative contributions of large artery disease and microvascular disease2 yearsCorrelation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRupak K Banerjee, PhD

University of Cincinnati , CVAMC

PRINCIPAL_INVESTIGATORMohamed Effat, MD

Univesity of Cincinnati, University Hospital

PRINCIPAL_INVESTIGATORImran Arif, MD

University of Cincinnati and University Hospital

PRINCIPAL_INVESTIGATORHanan Kerr, MD

University of Cincinnati

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026