Posted March 5, 2007
Researchers at the Idaho State University Family Medicine Clinical Research Center are seeking volunteers to participate in a new long-term cholesterol-lowering study in patients with heart disease.
This research project is called AIM-HIGH and is funded by the National Heart, Lung, and Blood Institute, a part of the National Institutes of Health, and receives additional support from Kos Pharmaceuticals. ISU is one of about 70 research centers across the United States and Canada participating in AIM-HIGH. The multi-year study brings about $510,000 to ISU Family Medicine Clinical Research Center, which is involved in other clinical studies, including another major clinical trial on diabetes, that presently generate more than $2 million in research funding.
For AIM-HIGH, the researchers are looking for about 60 volunteers at ISU and about 5,500 total nationwide. Volunteers must be 45 years of age or older, have cardiovascular disease and have an imbalance of good and bad cholesterol – low HDL-cholesterol plus elevated triglycerides. Potential volunteers will be given an exam to determine if they are qualified to enroll in the study. The must have vascular disease in combination with low HDL-cholesterol and high triglycerides, and have no conditions that would prevent their participation.
Those selected will all be given Zocor®, a drug proven to lower the level of LDL cholesterol, the so-called “bad cholesterol” that often contributes to episodes of heart disease. Participants will then be given either a placebo or the drug Niaspan®. The latter drug raises the level of HDL or “good cholesterol” and lowers the levels of triglycerides. A few patients may require a third drug, Zetia® to help lower their LDL cholesterol levels.
The main question the study will answer is whether the combination of the two drugs that increase the levels of the good cholesterol add to the already well-established benefits of the bad-cholesterol lowering drugs. The drugs provided in this study are free to the participants. The FDA has approved all the drugs that will be used in the study.
“Traditionally, heart disease treatments have keyed on lowering bad cholesterol,” said Dr. Rex Force, professor of family medicine and pharmacy practice, and director of
research, grants and information systems at the Family Medicine Clinical Research Center. “But in this study we’re looking at raising the level of good cholesterol and seeing if it makes a difference.”
Force and Dr. Nicole Murdock, ISU Clinical Assistant Professor in Pharmacy Practice and Family Medicine, are the co-principal investigators for this long-term study. “This is an outcome-based study,” Murdock said. “We will follow these volunteers for five years and note whether the new treatment reduced the number of heart attacks, strokes and cardiovascular disease.”
Most volunteers at the ISU clinic in Pocatello will come from southeast Idaho, but some study participants may come from as far away as southwest Idaho, Montana, Wyoming and Utah, as they have in previous clinical trials.
The time commitment for participating is minimal: initially volunteers will have to meet with researchers four times the first few months of the study, then just twice a year for the rest of the study.
For more information about volunteering for the study, contact Force at (208) 282-4508 or firstname.lastname@example.org, or, Murdock at (208) 282-4467 or email@example.com.
The ISU Family Medicine Clinical Research Center is located at 465 Memorial Drive, Pocatello.