Simultaneous Measurements Of Pressure Gradient, Blood Flow and Percentage Area Stenosis Of Coronary Epicardial Lesions To Assess Severity Of Epicardial Stenosis And Myocardial Infarction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Cincinnati
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- 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
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
CDP LFC
all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR
Intervention: FFR/CFR and IVUS (Device)
Outcomes
Primary Outcomes
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
Time Frame: Upon Diagnostic Angiogram and Flow Wire
Secondary Outcomes
- 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)
Investigators
Rupak K. Banerjee
Professor
University of Cincinnati