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

NCT ID: NCT01581671

Last Updated: 2014-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 201 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-06-30

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients having a first time angiogram

Patients who are coming to the Cardiac Cath Lab to have an angiogram for the first time

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Itamar-Medical, Israel

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Amir Lerman

MD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Lerman, B.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

10-005160

Identifier Type: -

Identifier Source: org_study_id