Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Cardiac PET, Coronary catheterization

• Registration Number: NCT01719016
• Lead Sponsor: University of Cincinnati

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).

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac PET, Coronary catheterization	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.

Primary Outcome Measures

Name	Time	Method
Quantification of relative contributions of large artery disease and microvascular disease	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 Outcome Measures

Name	Time	Method
Quantification of relative contributions of large artery disease and microvascular disease	2 years	Correlation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values.

Trial Locations

Locations (1)

Cincinnati Veteran Affairs Medical Center; 🇺🇸 Cincinnati, Ohio, United States