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Clinical Trials/NCT01719016
NCT01719016
Active, Not Recruiting
N/A

Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics

University of Cincinnati1 site in 1 country68 target enrollmentAugust 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of Cincinnati
Enrollment
68
Locations
1
Primary Endpoint
Quantification of relative contributions of large artery disease and microvascular disease
Status
Active, Not Recruiting
Last Updated
11 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
July 30, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rupak K. Banerjee

Professor

University of Cincinnati

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

Outcomes

Primary Outcomes

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

  • Quantification of relative contributions of large artery disease and microvascular disease(2 years)

Study Sites (1)

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