Measurements to Assess Severity of Epicardial Stenoses (MASES)

September 3, 2010 updated by: University of Cincinnati

Simultaneous Measurements Of Pressure Gradient, Blood Flow and Percentage Area Stenosis Of Coronary Epicardial Lesions To Assess Severity Of Epicardial Stenosis And Myocardial Infarction

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Volcano FFR and IVUS catheters will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Upon Diagnostic Angiogram and Flow Wire

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Upon Diagnostic Angiogram and Flow Wire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

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: Srikara Pellukhana, BS, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ANTICIPATED)

October 1, 2011

Study Completion (ANTICIPATED)

April 1, 2012

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (ESTIMATE)

September 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 6, 2010

Last Update Submitted That Met QC Criteria

September 3, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCIRB08031108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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