Correlation of Endothelial Function and Early Coronary Artery Disease in Humans

Endothelial Dysfunction Clinical Trial

Official title:

Endothelin in the Coronary Circulation in Early Atherosclerosis in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271492
• Other study ID #: 48-99
• Status: Completed
• Phase: Phase 3
• First received: December 29, 2005
• Last updated: April 28, 2010
• Start date: July 2001
• Est. completion date: January 2008

Study information

• Verified date: April 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Drug:
• Atrasentan
1 10mg capsule to be taken daily for 6 month study period.
• Atrasentan
1 10mg capsule per day for the 6 month study period.
• atrasentan
One 10 mg capsule per day for 6 month study period

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To find out what effects (good and bad) the medication Atrasentan has on the heart		6 months	Yes

External Links

•   Mayo Clinic Clinical Trials