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

This study has been completed.
Itamar-Medical, Israel
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic Identifier:
First received: November 22, 2011
Last updated: June 24, 2014
Last verified: June 2014
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.

Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Peripheral Arterial Tonometry (EndoPAT) Increases Diagnostic Yield of Coronary Artery Disease by Coronary Angiography

Resource links provided by NLM:

Further study details as provided by Amir Lerman, Mayo Clinic:

Primary Outcome Measures:
  • 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.

Enrollment: 201
Study Start Date: September 2010
Study Completion Date: June 2014
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Patients having a first time angiogram
Patients who are coming to the Cardiac Cath Lab to have an angiogram for the first time

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients coming to the Cardiac Cath Lab to determine if they have coronary artery disease

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01581671

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Itamar-Medical, Israel
Principal Investigator: Amir Lerman, B.D. Mayo Clinic
  More Information

Responsible Party: Amir Lerman, MD, Principal Investigator, Mayo Clinic Identifier: NCT01581671     History of Changes
Other Study ID Numbers: 10-005160
Study First Received: November 22, 2011
Last Updated: June 24, 2014

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on August 18, 2017