Measurements to Assess Severity of Epicardial Stenoses

Coronary Artery Disease Clinical Trial

— MASES  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00760630
• Other study ID #: UCIRB08031108
• Status: Suspended
• Phase: Phase 0
• First received: September 24, 2008
• Last updated: September 3, 2010
• Start date: December 2009
• Est. completion date: April 2012

Study information

• Verified date: September 2010
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 76
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• FFR/CFR and IVUS
All patients with clinical indication for cardiac cath will have FFR and IVUS

Locations

Country	Name	City	State
United States	Department of Veterans Affairs	Cincinnati	Ohio
United States	University Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No