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NCT Number: NCT01719016

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Veteran Affairs Medical Center

Cincinnati, Ohio, 45220, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac PET, Coronary catheterization

Procedure

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: Volcano therapeutics, Combomap machine, Adenosine, Lexiscan, N-13 Ammonia

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2012
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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