Clinical Research, Quality Initiatives

As part of its ongoing commitment to excellence, Baptist Cardiovascular Services participates in national clinical research studies and quality review programs.

National Cardiovascular Data Registry (NCDR) : A Quality Initiative for the Treatment of Patients With Chest Pain
Baptist Heart Services participates in ACTION, a national program coordinated by Duke Clinical Research Institute that analyzes and modifies treatment patterns of over 200,000 patients suffering from Acute Coronory Syndrome (chest pain) across the United States. Baptist is one of 600 hospitals across the US participating in this study. Within this program, Baptist Cardiovascular Services has received an Outstanding Care Award. Only 10 percent of participating hospitals nationwide were awarded this recognition.

CREST: Clinical Research for the Prevention of Stroke
Baptist has been selected as one of 110 sites in the United States and Canada and the only site in Mississippi to participate in a study helping physicians find a better way to prevent strokes in people who have a narrowing in the carotid artery. This study is referred to as the CREST Trial, which stands for Carotid Revascularization Endarterectomy vs. Stenting Trials.

The Neurological Disorders and Stroke section of the National Institutes of Health and the Food and Drug Administration are sponsoring this research. The study will compare carotid endarterectomy, a common operation to prevent stroke, to a minimally invasive procedure, called carotid artery stenting. Patients who agree to participate in the CREST study will randomly receive either carotid endarterectomy or carotid artery stenting to treat the narrowed area in their carotid artery.

Cardiovascular Surgeon Charles O’Mara, MD, serves as Baptist’s primary investigator for the study. He said, “Physicians are trying to determine the safest way to prevent strokes in people who have a partial blockage or narrowing of the carotid artery.” The carotid arteries are located on each side of the neck and are the primary source of blood supply to the brain. A severe narrowing of a carotid artery can predispose a person to stoke occurrence.

Carotid endarterectomy for many years has been an effective method of treating carotid stenosis and preventing stroke. With this operation, a surgeon cleans out and repairs a narrowed carotid artery using an incision on the side of the neck usually under general anesthesia. Recently, carotid artery stenting was approved as an option for patients with health problems that increase their risk for carotid endarterectomy surgery. During this minimally invasive stenting procedure a metal device called a stent is placed in a narrowed part of the carotid artery to cover the plaque and hold the vessel open. The stent placement is done under x-ray control using a catheter introduced into a groin artery under local anesthesia.

“The study is to evaluate the usefulness of carotid stenting in patients who are not high surgical risk. The information we get from this study will influence the way we treat carotid disease probably for generations to come,” Dr. O’Mara continued. “It is anticipated that information obtained from the study will help to determine the specific clinical circumstances in which stenting will be safest and most effective, as well as those circumstances in which endarterectomy will be safest and most effective. Therefore it truly is a landmark study, and we appreciate the opportunity to contribute to the trial.”

Baptist is currently recruiting patients. The national goal is to obtain 1400 symptomatic patients and 1100 asymptomatic patients, and the tentative last year for enrolling patients is 2008. Participants will include men and women over 18 years old who have moderate to severe narrowing of at least one of their carotid arteries and have had either a small stroke or a temporary stroke called a transient ischemic attack (TIA), or have at least 60 percent blockage and no stroke or TIA symptoms within the last six months.

Other medical staff participating in this trial for Baptist include: Cardiologist Chris Waterer, MD; Cardiovascular Surgeons Victor Weiss, MD and Stewart Horsley, MD; Neurologists Richard Weddle, MD, and Gerald P. Randle, MD; and Baptist Cardiovascular Diagnostic Director Judy Henderson, RN, serving as the study clinical coordinator.

A patient diagnosed with carotid artery disease may be referred by their physician to one of the investigators listed above to enroll in the trial.

For more information about CREST:
Call the Baptist Health Line at 1-800-948-6262 or 601-948-6262
Contact Judy Henderson at jhenderson@mbhs.org

Web Resources
Learn more about CREST at the following websites:
www.cresttrial.org
www.clinicaltrials.gov