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Introduction to Clinical Trials
Introduction to Clinical Trials
Review frequently asked questions and introductory information about clinical trials.
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List of Clinical Trials
Open Clinical Trial
Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) Randomized and Multi-Center, Two-Group Clinical Trial to Assess the Best Treatment for Patients with High Blood Pressure and Renal Artery Stenosis (kidney artery blockage): Stenting with Anti-Hypertensive Medical Therapy Compared to Medical Therapy Alone.
Renal artery stenosis, which is a blockage of blood flow to the kidney, is a common problem, present in roughly 1-5% of the 60 million Americans with high blood pressure, and in many with decreased blood flow in the legs and/or heart because of blockages in the arteries without high blood pressure.
Although renal artery stenosis is regulary identified there has been no clear treatment for this disorder. The study will involve the use of a renal artery stent and blood pressure medication compared to blood pressure medication alone.
Phase
II
Compensation
N
Inclusion
1. Documented history of high blood pressure (hypertension) on 2 or more anti-hypertensive medications OR decreased kidney function.
2. One or more severe renal artery narrowing, diagnosed by any of the following pathways:
a. angiographic: >60% and <100% by renal angiogram OR
b. kidney ultrasound
c. MRA demonstrating renal arter blockage greater than 80%
d. CT angiogram demonstrating renal artery blockage more than 70%-80%
Exclusion
1. Age <18
2. Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization.
3. Pregnancy or unkown pregnancy status in female of childbearing potential.
4. History of stroke within 6 months, if associated with a residual neurological deficit
5.Any planned major surgery, major trauma, unstable angina, myocardial infarction or revascularization procedure 30 days prior to entry to study.
6. Hospitalization for heart failure within 30 days.
7.Allergic reaction to intravascular contrast, not amenable to pre-treatment
8.Allergic to stainless steel.
9.Allergy to all of the following: aspirin, clopidogrel, ticlopidine
10. Known untreated aneurysm of the abdominal aorta >5.0 cm.
11. Previous kidney transplant.
12. Creatinine >4.0 mg/dl
Research Study Site
Mount Sinai Medical Center
Department Name
MSSM Cardiovascular Institute
Contact Information
Patricia M Mcmullen [Coordinator]
RN, NP
patricia.mcmullen@mountsinai.org
212 241-0740 40740
GCO Number
05-1425
IRB Start/End Date
April 18, 2009 to April 17, 2010
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