Measurements to Assess Severity of Epicardial Stenoses

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: FFR/CFR and IVUS

• Registration Number: NCT00760630
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-26
• Study Start: 2009-12
• Status Verified: 2011-10
• Primary Completion: 2012-02-24
• Study Completion: 2012-02-24
• Last Update Submitted: 2024-12-21
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• LV < or + to 25% Serum Creatinine > 2.5 gm/dL Type II HIT Significant co-morbidities Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CDP LFC	FFR/CFR and IVUS	all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

University Hospital; 🇺🇸 Cincinnati, Ohio, United States

Department of Veterans Affairs; 🇺🇸 Cincinnati, Ohio, United States