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Clinical Trials : Sponsored Trial

Abdominal Aortic Aneurysms: Simple Treatment or Prevention
(AAA : STOP)

This study is sponsored by the National Institutes of Health - Heart, Lung and Blood Institute.

Abstract:

Abdominal aortic aneurysm (AAA) is a common and frequently lethal disease of older Americans. No medical therapy has been proven effective in retarding progression of small AAAs prior to surgical repair.  With the emerging ability of magnetic resonance (MR) flow imaging and MR-based computational analysis to define aortic hemodynamic conditions, and bio-imaging strategies to monitor aortic inflammation real time in vivo, the opportunity now exists to confirm the potential value of medical interventions such as supervised exercise training as first line therapy for small AAA disease.

Goal:

The goal of this study is to determine whether an exercise program reduces the rate of AAA enlargement and to gather information on AAA risk factors.

Study Overview and Design:
AAAs are common among older individuals, and are the 10th leading cause of death for men over the age of 55. A ruptured AAA usually leads to death. Therefore, early detection and treatment are critical. Currently, there are several surgical treatment options available, but there is no proven non-surgical treatment for AAAs. Research has shown that physical inactivity may be linked to the development of AAAs. The purpose of this study is to gather information on AAA risk factors, and to evaluate the effectiveness of an exercise program at preventing the growth of small AAAs in older individuals.

This study will be composed of three individual projects. Project 1 will enroll 1400 individuals with newly diagnosed small AAAs. Project 2 will enroll 1000 individuals with unknown aortic size and previously tested exercise capacity. Both groups of participants will attend one study visit, at which time their medical history will be reviewed, vital signs will be recorded, and blood and urine sample will be collected. Questionnaires will be completed to document physical activity levels and AAA risk factors. An abdominal ultrasound will be performed to measure the size of the aorta or AAA. Participants in Project 2 will also take part in a treadmill exercise test, during which heart rate and blood pressure will be recorded, and heart activity will be monitored by an electrocardiogram (ECG).

The third project will last 3 years and will enroll 340 individuals from Project 1. Participants will be randomly assigned to either an exercise program or a usual activity group. An initial screening visit will include medical history review, vital sign measurements, blood collection, questionnaires, an abdominal ultrasound, a positron emission tomography (PET) scan, a computed tomography (CT) scan, and a magnetic resonance imaging (MRI) scan.

Participants in the exercise program will complete an exercise test at the beginning of the study and every 6 months for the duration of the study. Participants who live within 15 miles of the Palo Alto VA Hospital will take part in a supervised aerobic exercise program 3 days a week. Participants who live farther than 15 miles from the hospital will receive a detailed exercise plan and will exercise on their own while wearing a heart rate and activity tracking device. They will also attend monthly study visits for review of their progress. All participants assigned to the exercise program will be encouraged to increase their daily exercise. Each day they will wear a pedometer; twice a month they will wear a global positioning system (GPS) and heart rate monitor. Participants assigned to the usual activity group will wear pedometers each day and will maintain their usual level of physical activity. At yearly study visits, blood will be collected and physical activity levels will be assessed.

All Project 3 participants with AAAs smaller than 4 cm will undergo an ultrasound and blood collection once a year; participants with AAAs 4 cm or larger will undergo the same procedures every 6 months. At the end of 3 years, all participants will attend a final study visit at which time their medical history will be reviewed and blood will be collected. They will also undergo an abdominal ultrasound, and PET, CT, and MRI scans.

Phase and Location

The study is currently in phase one and it is located in Palo Alto, California. 

Enrollment
Enrollment eligibility for the exercise trial will conclude in December 2007, but enrollment for the other projects will continue until 2010. 

AAA: STOP website:

http://aaastop.stanford.edu

Contacts:

Ronald L. Dalman, MD – Principal Investigator

rld@stanford.edu


Lawrence Leung, MD – Co-Principal Investigator
Philip S. Tsao, PhD – Project II Leader
Charles A. Taylor, PhD – Project III Leader
Jonathan Myers, PhD – Project IV Co-Leader


Julie White – AAA STOP Program Coordinator

jljwhite@stanford.edu

(650) 498-6039

This information is included for patient information only. The Vascular Disease Foundation does not endorse any clinical research studies.