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NCT01581671 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01581671
Other study ID # 10-005160
Secondary ID
Status Completed
Phase N/A
First received November 22, 2011
Last updated June 24, 2014
Start date September 2010
Est. completion date June 2014

Study information
Verified date June 2014
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 201
Est. completion date June 2014
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Itamar-Medical, Israel

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine if the assessment of endothelial function by non-invasive peripheral arterial tonometry improves diagnostic yield of elective coronary angiography 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 No
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