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Measurements to Assess Severity of Epicardial Stenoses (MASES)

This study has suspended participant recruitment.
(IRB Approval on study expired May 28, 2009)
Sponsor:
Collaborator:
American Heart Association
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00760630
First received: September 24, 2008
Last updated: September 3, 2010
Last verified: September 2010
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

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: December 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDP LFC
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
Other Name: Volcano FFR and IVUS catheters will be used

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

Locations
United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45219
Department of Veterans Affairs
Cincinnati, Ohio, United States, 45220
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

No publications provided

Responsible Party: Imran Arif, MD, UNIVERSITY OF CINCINNATI
ClinicalTrials.gov Identifier: NCT00760630     History of Changes
Other Study ID Numbers: UCIRB08031108
Study First Received: September 24, 2008
Last Updated: September 3, 2010
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013