Clinical trial NCT01719016: Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics
Official title: Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid Dynamics
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: Reversible ischemia
microvascular dysfunction
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chest pain and suspected ischemia that needs to be assessed by a stress test

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).

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

Primary outcomes:
measure: Quantification of relative contributions of large artery disease and microvascular disease
timeFrame: 2 years
Secondary outcomes:
measure: Quantification of relative contributions of large artery disease and microvascular disease
timeFrame: 2 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Veteran Affairs Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati , CVAMC
name: Rupak K Banerjee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univesity of Cincinnati, University Hospital
name: Mohamed Effat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati and University Hospital
name: Imran Arif, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Hanan Kerr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.