Measurements to Assess Severity of Epicardial Stenoses (MASES)

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: FFR/CFR and IVUS

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.

• Study Type: Observational
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University Hospital
    • Cincinnati, Ohio, United States, 45220
      • Department of Veterans Affairs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with chest pain and suspected ischemia that needs to be assessed by a stress test

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CDP LFC; all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR	Device: FFR/CFR and IVUS; All patients with clinical indication for cardiac cath will have FFR and IVUS; Other Names: Volcano FFR and IVUS catheters will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 measurements	Upon Diagnostic Angiogram and Flow Wire

Secondary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Mohamed Effat, MD, University of Cincinnati; Principal Investigator: Kranthi K Kolli, MS, University of Cincinnati; Principal Investigator: Massoud Leesar, MD, University of Cincinnati; Principal Investigator: Rupak Banerjee, PhD, University of Cincinnati; Principal Investigator: Srikara Pellukhana, BS, University of Cincinnati; Principal Investigator: Tarek Helmy, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): February 24, 2012
• Study Completion (Actual): February 24, 2012

Study Registration Dates

• First Submitted: September 24, 2008
• First Submitted That Met QC Criteria: September 24, 2008
• First Posted (Estimated): September 26, 2008

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: fractional flow reserve; abnormal stress test; pressure drop coefficient; lesion flow coefficient
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: UCIRB08031108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes