Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

NCT01719016 | Active Not Recruiting

• 1 other identifier: 10-05-05-02
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Reversible ischemia; microvascular dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quantification of relative contributions of large artery disease and microvascular disease

  2 years

Study Arms (1)

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

Interventions

Cardiac PET, Coronary catheterization 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

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

Cardiac PET, Coronary catheterization

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Cincinnati Veteran Affairs Medical Center

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• 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.

  PMID: 34335296 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Adenosine; regadenoson

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 1, 2012
• Study Start: August 1, 2010
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

US (1)