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Measurements to Assess Severity of Epicardial Stenoses (MASES)

Primary Purpose

Coronary Artery Disease

Status

Suspended

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

FFR/CFR and IVUS

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring abnormal stress test, fractional flow reserve, pressure drop coefficient, lesion flow coefficient

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital
Department of Veterans Affairs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CDP LFC

Arm Description

all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR

Outcomes

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

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).

Full Information

NCT ID

NCT00760630

First Posted

September 24, 2008

Last Updated

September 3, 2010

Sponsor

University of Cincinnati

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT00760630

Brief Title

Measurements to Assess Severity of Epicardial Stenoses

Acronym

MASES

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Suspended

Why Stopped

IRB Approval on study expired May 28, 2009

Study Start Date

December 2009 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Cincinnati

Collaborators

American Heart Association

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CDP LFC

Arm Type

Experimental

Arm Description

all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR

Intervention Type

Device

Intervention Name(s)

FFR/CFR and IVUS

Other Intervention Name(s)

Volcano FFR and IVUS catheters will be used

Intervention Description

All patients with clinical indication for cardiac cath will have FFR and IVUS

Primary Outcome Measure Information:

Title

Time Frame

Upon Diagnostic Angiogram and Flow Wire

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: