Measurements to Assess Severity of Epicardial Stenoses - Full Text View

Sponsors and Collaborators:	University of Cincinnati American Heart Association
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00760630

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: FFR/CFR and IVUS	Phase 0

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment
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

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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). [ Time Frame: Upon Diagnostic Angiogram and Flow Wire ] [ Designated as safety issue: No ]

Estimated Enrollment:	76
Study Start Date:	January 2009
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CDP LFC: Experimental all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR	Device: FFR/CFR and IVUS All patients with clinical indication for cardiac cath will have FFR and IVUS

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760630

Contacts

Contact: Cindy Werner, RN, BSN	513-558-1331	cindy.werner@uc.edu
Contact: Rupak K Banerjee, PhD	513-556-2124	rupak.banerjee@uc.edu

Locations

United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45219

Sponsors and Collaborators

University of Cincinnati

American Heart Association

Investigators

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

More Information

Responsible Party:	UNIVERSITY OF CINCINNATI ( TAREK HELMY, MD )
Study ID Numbers:	UCIRB08031108
Study First Received:	September 24, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00760630
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

abnormal stress test
fractional flow reserve
pressure drop coefficient
lesion flow coefficient

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Stress

Constriction, Pathologic
Arteriosclerosis
Ischemia
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009