Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

Coronary Artery Disease Clinical Trial

Official title:

Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01719016
• Other study ID #: 10-05-05-02
• Status: Active, not recruiting
• Start date: August 2010
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Cardiac PET, Coronary catheterization
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

Locations

Country	Name	City	State
United States	Cincinnati Veteran Affairs Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantification of relative contributions of large artery disease and microvascular disease	Correlation of CDP and LFC with invasively measured Fractional Flow Reserve (FFR) values.	2 years