Clinical trial NCT00271492: Correlation of Endothelial Function and Early Coronary Artery Disease in Humans
Official title: Endothelin in the Coronary Circulation in Early Atherosclerosis in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endothelial Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-01-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To find out what effects (good and bad) the medication Atrasentan has on the heart
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reriani M, Raichlin E, Prasad A, Mathew V, Pumper GM, Nelson RE, Lennon R, Rihal C, Lerman LO, Lerman A. Long-term administration of endothelin receptor antagonist improves coronary endothelial function in patients with early atherosclerosis. Circulation. 2010 Sep 7;122(10):958-66. doi: 10.1161/CIRCULATIONAHA.110.967406. Epub 2010 Aug 23.