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Measurements to Assess Severity of Epicardial Stenoses

Simultaneous Measurements Of Pressure Gradient, Blood Flow and Percentage Area Stenosis Of Coronary Epicardial Lesions To Assess Severity Of Epicardial Stenosis And Myocardial Infarction

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00760630
Acronym
MASES
Enrollment
10
Registered
2008-09-26
Start date
2009-12-01
Completion date
2012-02-24
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

abnormal stress test, fractional flow reserve, pressure drop coefficient, lesion flow coefficient

Brief summary

Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.

Detailed description

The pressure drop coefficient (CDP) is a functional index based on hyperemic dp and u measurements. The lesion flow coefficient (LFC) combines the functional index CDP with an atomic measure (percentage area stenosis) as a single parameter.

Interventions

DEVICEFFR/CFR and IVUS

All patients with clinical indication for cardiac cath will have FFR and IVUS

Sponsors

University of Cincinnati
Lead SponsorOTHER
American Heart Association
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Abnormal Myocardial stress perfusion (SPECT) LV EF \> 25% * 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

* Serum Creatinine \> 2.5 gm/dL * Type II HIT * Left ventricular ejection fraction less the 25% determined by gated SPECT imaging ( - LV \< or + to 25%) * 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

Design outcomes

Primary

MeasureTime frame
to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurementsUpon Diagnostic Angiogram and Flow Wire

Secondary

MeasureTime frame
To compare novel measurements, Pressure Drop Coefficient (CDP) & Lesion Flow Coefficient (LFC), against measured current parameters called Fractional flow reserve (FFR) & Coronary flow reserve (CFR).Upon Diagnostic Angiogram and Flow Wire

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMohamed Effat, MD

University of Cincinnati

PRINCIPAL_INVESTIGATORKranthi K Kolli, MS

University of Cincinnati

PRINCIPAL_INVESTIGATORMassoud Leesar, MD

University of Cincinnati

PRINCIPAL_INVESTIGATORRupak Banerjee, PhD

University of Cincinnati

PRINCIPAL_INVESTIGATORTarek Helmy, MD

University of Cincinnati

PRINCIPAL_INVESTIGATORSrikara Pellukhana, BS

University of Cincinnati

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026