Correlation of Endothelial Function and Early Coronary Artery Disease in Humans

April 28, 2010 updated by: Mayo Clinic

Endothelin in the Coronary Circulation in Early Atherosclerosis in Humans

Qualifying patients who are scheduled for angiogram with endothelial function testing are approached to participate in this protocol (consent form reviewed with patient). Those who are willing to participate will have additional measurements taken during their angiogram as part of this protocol. Patients who are diagnosed with Endothelial Dysfunction as a result of a clinically indicated angiogram will be eligible to participate in a 6 month medication trial (Atrasentan vs. placebo - randomized, blinded trial). Patients are monitored closely during the 6 month trial via phone calls and blood testing for assessment. At the end of the 6 months they return to Mayo for a repeat angiogram to assess endothelial function for any changes or improvements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim I: To determine the activity of the endogenous endothelin system in the coronary circulation in humans with coronary endothelial dysfunction and atherosclerosis risk factors. Aim II: To assess the potential of chronic endothelin receptor antagonists to improve preexisting coronary endothelial dysfunction and myocardial perfusion in humans and Aim III: To assess the effect of chronic endothelin receptor antagonism on the endogenous nitric oxide system in association with oxidative stress in humans with early coronary disease risk factors.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years and < 85 years
  • Male or female

Exclusion criteria:

  • Left dominant circulation
  • Heart failure with EF <40%
  • Unstable angina
  • MI or angioplasty of the LAD or circumflex with 6 months prior to entry into the study
  • Use of radiographic contrast agent within 12 hours of entry into the study
  • Use of investigational agents within one month of entry into the study
  • Patients who require treatment with positive inotropic agents other than digoxin during the study
  • Patients with cerebrovascular accident within 6 months prior to entry into the study
  • Significant endocrine, hepatic, renal disorders; local or systemic infectious disease within 4 weeks prior to entry into study
  • Pregnancy or lactation
  • Mental instability
  • Federal Medical Center patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I
Qualifying patients took Atrasentan, 1 pill per day for 6 months, to determine if it had a favorable affect on patients who took it over those who were randomized to placebo.
Drug: Atrasentan
1 10mg capsule to be taken daily for 6 month study period.
Other Names:
  • Xinlay
Drug: Atrasentan
1 10mg capsule per day for the 6 month study period.
Other Names:
  • Xinlay
Placebo Comparator: 2
placebo group to be compared to the actual medication
Drug: atrasentan
One 10 mg capsule per day for 6 month study period
Other Names:
  • Xinlay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To find out what effects (good and bad) the medication Atrasentan has on the heart
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

December 29, 2005

First Submitted That Met QC Criteria

December 29, 2005

First Posted (Estimate)

January 2, 2006

Study Record Updates

Last Update Posted (Estimate)

April 30, 2010

Last Update Submitted That Met QC Criteria

April 28, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48-99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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