Non-Invasive EndoPAT Increases Diagnostic Yield of CAD by Coronary Angiography

June 24, 2014 updated by: Amir Lerman, Mayo Clinic

Non-Invasive Peripheral Arterial Tonometry (EndoPAT) Increases Diagnostic Yield of Coronary Artery Disease by Coronary Angiography

The purpose of this study is to assess the non-invasive, Peripheral Arterial Tonometry (PAT) testing as another way of predicting potential coronary artery blockages in the heart.

Study Overview

Status

Completed

Conditions

Detailed Description

We are conducting a 16 minute, non-invasive EndoPAT test on patients coming to our cath lab for a first-time angiogram. The angiogram results will be compared to the EndoPAT results to determine if the EndoPAT test, which generates a score, is successful in predicting who may have blockages in their coronary arteries.

Study Type

Observational

Enrollment (Actual)

201

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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients coming to the Cardiac Cath Lab to determine if they have coronary artery disease

Description

Inclusion Criteria:

  • Patients without known coronary disease who are referred for coronary angiography.
  • Adults 18 years and older.

Exclusion Criteria:

  • Patients with known coronary disease, acute coronary syndrome, cardiac transplantation, and severe connective tissue disease.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients having a first time angiogram
Patients who are coming to the Cardiac Cath Lab to have an angiogram for the first time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine if the assessment of endothelial function by non-invasive peripheral arterial tonometry improves diagnostic yield of elective coronary angiography
Time Frame: same day as the angiogram
Will compare the score of the EndoPAT test to the outcome of the angiogram to determine if the score is predictive of coronary artery disease.
same day as the angiogram

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

Itamar-Medical, Israel

Investigators

  • Principal Investigator: Amir Lerman, B.D., Mayo Clinic

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

September 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-005160

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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