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

This study is currently recruiting participants.

Verified October 2012 by Mayo Clinic

Sponsor:

Collaborator:

Itamar-Medical, Israel

Information provided by (Responsible Party):

Amir Lerman, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01581671

First received: November 22, 2011

Last updated: October 23, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 22, 2011

Last Updated Date

October 23, 2012

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01581671 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients having a first time angiogram

Patients who are coming to the Cardiac Cath Lab to have an angiogram for the first time

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

330

Estimated Completion Date

December 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Rebecca E. Nelson, CCRC

507-255-8388

nelson.rebecca@mayo.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01581671

Other Study ID Numbers ^ICMJE

10-005160

Has Data Monitoring Committee

Responsible Party

Amir Lerman, Mayo Clinic

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

Itamar-Medical, Israel

Investigators ^ICMJE

Principal Investigator:

Amir Lerman, B.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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