Indiana University is recruiting participants for a national study to measure the effectiveness of stents to treat atherosclerotic renal artery stenosis, or narrowing of the kidney arteries.

The medical center seeks participants for the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study, a $28 million project funded by the National Institutes of Health. The study is recruiting more than 1,000 participants at 100 sites in the United States.

People may qualify for the CORAL study if they have atherosclerotic renal artery stenosis with high blood pressure. The disease affects as many as 3 million Americans, primarily over the age of 50, and brings a high risk of heart attack, stroke, heart failure, kidney failure and death.

During the study, participants will be randomized to one of two groups. They will receive medication alone to control blood pressure and other risk factors, or they will be treated with medication and placement of a stent in the blocked kidney artery. Participants will be followed for the duration of the six-year study to determine which treatment reduces incidences of heart attack, heart failure, stroke and kidney failure.

Historically, medication has been used to control high blood pressure and associated problems. With advances in technology, balloon angioplasty and stents - treatments used to open a blocked artery - have been used increasingly, without evidence that they reduce the risk of heart and kidney problems. The CORAL study will examine whether inserting a stent to keep the artery open will lead to better outcomes for patients.

Blockage of the kidney arteries is one of the two major causes of high blood pressure, occurring in 1 percent to 5 percent of patients. In patients who have accelerated high blood pressure, the prevalence of blocked kidney arteries is much higher, ranging from 10 percent to 40 percent.

If the disease is caught early, about half of patients who have blockage in one artery benefit from opening the blockage with a stent. Physicians have tried to identify these patients who could benefit from intervention, but the disease is difficult to diagnose through imaging scans and other means. Patients may have other symptoms or problems that indicate renal artery stenosis, such as known carotid artery disease; coronary artery disease (such as angina pectoris, prior heart attack, or prior coronary artery stent or bypass surgery); or leg artery circulation problems.

"Nationwide, we spend over $1.5 billion annually opening narrowed renal arteries, because we think it can improve high blood pressure and prevent devastating complications such as heart attack and stroke. But the fact is we don't know for sure if it works. We must answer the question: 'Does it work?' That is why the CORAL study is so important," says Thomas Casciani, M.D., associate professor of interventional radiology and the principal investigator for the CORAL study at Indiana University School of Medicine.


To enroll in the CORAL study, call the IU radiology research coordinator at 317-278-3834.

For more information, go to coralclinicaltrial
Indiana University

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