Correlation of Endothelial Function and Early Coronary Artery Disease in Humans - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Institutes of Health (NIH)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00271492

Purpose

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.

Condition	Intervention	Phase
Endothelial Dysfunction	Drug: Atrasentan Drug: atrasentan	Phase III

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Atrasentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Endothelin in the Coronary Circulation in Early Atherosclerosis in Humans

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

To find out what effects (good and bad) the medication Atrasentan has on the heart [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	July 2001
Study Completion Date:	January 2008
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator 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. Drug: Atrasentan 1 10mg capsule per day for the 6 month study period.
2: Placebo Comparator placebo group to be compared to the actual medication	Drug: atrasentan One 10 mg capsule per day for 6 month study period

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

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271492

Locations

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

Sponsors and Collaborators

Mayo Clinic

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Amir Lerman, M.D.

Mayo Clinic

More Information

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	Mayo Clinic ( Amir Lerman, M.D. )
Study ID Numbers:	48-99
Study First Received:	December 29, 2005
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00271492
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009