Study Stopped
IRB Approval expired on 05/28/09 as it was pilot study. A new study was later initiated once VA Merit Review Grant (I01CX000342-01) was received. Thus a new IRB (10-05-05-02) and clinicaltrials.gov (NCT01719016) were initiated in place of this study.
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
1 other identifier
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Dec 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2012
CompletedDecember 27, 2024
October 1, 2011
2.2 years
September 24, 2008
December 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
CDP LFC
EXPERIMENTALall patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR
Interventions
All patients with clinical indication for cardiac cath will have FFR and IVUS
Eligibility Criteria
You may qualify if:
- Abnormal Myocardial stress perfusion (SPECT) LV EF \> 25%
You may not qualify if:
- LV \< or + to 25% Serum Creatinine \> 2.5 gm/dL Type II HIT Significant co-morbidities Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cincinnatilead
- American Heart Associationcollaborator
Study Sites (2)
University Hospital
Cincinnati, Ohio, 45219, United States
Department of Veterans Affairs
Cincinnati, Ohio, 45220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Tarek Helmy, MD
University of Cincinnati
- PRINCIPAL INVESTIGATOR
Srikara Pellukhana, BS
University of Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 24, 2008
First Posted
September 26, 2008
Study Start
December 1, 2009
Primary Completion
February 24, 2012
Study Completion
February 24, 2012
Last Updated
December 27, 2024
Record last verified: 2011-10