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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581671
First Posted: April 20, 2012
Last Update Posted: June 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Itamar-Medical, Israel
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
November 22, 2011
April 20, 2012
June 25, 2014
September 2010
April 2012   (Final data collection date for primary outcome measure)
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 as current
Complete list of historical versions of study NCT01581671 on ClinicalTrials.gov Archive Site
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Non-Invasive EndoPAT Increases Diagnostic Yield of CAD by Coronary Angiography
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients coming to the Cardiac Cath Lab to determine if they have coronary artery disease
Coronary Artery Disease
Not Provided
Patients having a first time angiogram
Patients who are coming to the Cardiac Cath Lab to have an angiogram for the first time
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
June 2014
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01581671
10-005160
No
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Amir Lerman, Mayo Clinic
Mayo Clinic
Itamar-Medical, Israel
Principal Investigator: Amir Lerman, B.D. Mayo Clinic
Mayo Clinic
June 2014