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Measurements to Assess Severity of Epicardial Stenoses

NCT ID: NCT00760630

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-02-24

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CDP LFC

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

Group Type EXPERIMENTAL

FFR/CFR and IVUS

Intervention Type DEVICE

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

Interventions

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FFR/CFR and IVUS

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

Intervention Type DEVICE

Other Intervention Names

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Volcano FFR and IVUS catheters will be used

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Rupak K. Banerjee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Effat, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Kranthi K Kolli, MS

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Massoud Leesar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Rupak Banerjee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Tarek Helmy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Srikara Pellukhana, BS

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University Hospital

Cincinnati, Ohio, United States

Site Status

Department of Veterans Affairs

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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UCIRB08031108

Identifier Type: -

Identifier Source: org_study_id