NCT01581671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 25, 2014

Status Verified

June 1, 2014

Enrollment Period

1.6 years

First QC Date

November 22, 2011

Last Update Submit

June 24, 2014

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • To determine if the assessment of endothelial function by non-invasive peripheral arterial tonometry improves diagnostic yield of elective coronary angiography

    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 day as the angiogram

Study Arms (1)

Patients having a first time angiogram

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients coming to the Cardiac Cath Lab to determine if they have coronary artery disease

You may qualify if:

  • Patients without known coronary disease who are referred for coronary angiography.
  • Adults 18 years and older.

You may not qualify if:

  • Patients with known coronary disease, acute coronary syndrome, cardiac transplantation, and severe connective tissue disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Amir Lerman, B.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

November 22, 2011

First Posted

April 20, 2012

Study Start

September 1, 2010

Primary Completion

April 1, 2012

Study Completion

June 1, 2014

Last Updated

June 25, 2014

Record last verified: 2014-06

Locations

US(1)