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

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ClinicalTrials.gov Identifier: NCT01581671
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : June 25, 2014
Sponsor:
Collaborator:
Itamar-Medical, Israel
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic

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.

Condition or disease
Coronary Artery Disease

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
Actual Enrollment : 201 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Peripheral Arterial Tonometry (EndoPAT) Increases Diagnostic Yield of Coronary Artery Disease by Coronary Angiography
Study Start Date : September 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.



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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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581671


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

Responsible Party: Amir Lerman, MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01581671     History of Changes
Other Study ID Numbers: 10-005160
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases