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

This study has been completed.
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: June 24, 2014
Last verified: June 2014
  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:


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.


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)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: June 24, 2014
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 August 21, 2014