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OpenTrials
Completed

NCT Number: NCT00271492

Correlation of Endothelial Function and Early Coronary Artery Disease 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.

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Key information

Conditions

Endothelial Dysfunction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atrasentan

Drug

1 10mg capsule to be taken daily for 6 month study period.

Other names: Xinlay

Primary outcomes

  1. To find out what effects (good and bad) the medication Atrasentan has on the heart

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Endothelin in the Coronary Circulation in Early Atherosclerosis in Humans

Important dates

Study start
2001
Primary completion
2006
Study completion
2008
First posted
Jan 2, 2006
Registry last updated
Apr 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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