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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
  Purpose

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
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:

U.S. FDA Resources

Further study details as provided by 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 ] [ 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.


Estimated Enrollment: 330
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581671

Contacts
Contact: Rebecca E. Nelson, CCRC 507-255-8388 nelson.rebecca@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Rebecca E. Nelson, CCRC     507-255-8388     nelson.rebecca@mayo.edu    
Principal Investigator: Amir Lerman, M.D.            
Sponsors and Collaborators
Mayo Clinic
Itamar-Medical, Israel
Investigators
Principal Investigator: Amir Lerman, B.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Amir Lerman, MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01581671     History of Changes
Other Study ID Numbers: 10-005160
Study First Received: November 22, 2011
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013