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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00760630
Other study ID # UCIRB08031108
Secondary ID
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


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
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