Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

September 1, 2026 updated by: Rupak K. Banerjee, University of Cincinnati
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac PET, Coronary catheterization

Cardiac PET scan:

  1. Injection of N-13 Ammonia radionuclide. 2 doses of 10 milliCuries and 20 milliCuries each.
  2. Injection of Lexiscan.

Coronary catheterization:

  1. Pressure and flow readings using Combowire
  2. 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:

  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
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
Time Frame: 2 years
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
Time Frame: 2 years
Correlation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

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)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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