Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

NCT ID: NCT01719016

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2025-07-30

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).

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cardiac PET, Coronary catheterization

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Volcano therapeutics; Combomap machine; Adenosine; Lexiscan; N-13 Ammonia

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Rupak K. Banerjee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rupak K Banerjee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati , CVAMC

Mohamed Effat, MD

Role: PRINCIPAL_INVESTIGATOR

Univesity of Cincinnati, University Hospital

Imran Arif, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati and University Hospital

Hanan Kerr, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

Cincinnati Veteran Affairs Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34335296 (View on PubMed)

Other Identifiers

10-05-05-02

Identifier Type: -

Identifier Source: org_study_id