Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Cardiac PET, Coronary catheterization

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).

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Veteran Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with chest pain and suspected ischemia that needs to be assessed by a stress test

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cardiac PET, Coronary catheterization; 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; 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; Other Names: Adenosine; Lexiscan; Volcano therapeutics; Combomap machine; N-13 Ammonia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Rupak K Banerjee, PhD, University of Cincinnati , CVAMC; Principal Investigator: Mohamed Effat, MD, Univesity of Cincinnati, University Hospital; Principal Investigator: Imran Arif, MD, University of Cincinnati and University Hospital; Principal Investigator: Hanan Kerr, MD, University of Cincinnati

Publications and helpful links

General Publications

• Banerjee RK, Ramadurai S, Manegaonkar SM, Rao MB, Rakkimuthu S, Effat MA. Comparison Between 5- and 1-Year Outcomes Using Cutoff Values of Pressure Drop Coefficient and Fractional Flow Reserve for Diagnosing Coronary Artery Diseases. Front Physiol. 2021 Jul 14;12:689517. doi: 10.3389/fphys.2021.689517. eCollection 2021.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimated): November 1, 2012

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: microvascular dysfunction; Reversible ischemia
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Nucleosides; Ribonucleosides; Purine Nucleosides; Adenosine; regadenoson
• Other Study ID Numbers: 10-05-05-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No