Clinical Research Directory

The Effect of a Multimodal Preventive Intervention in Patients With Asymptomatic Peripheral Artery Disease

This pilot study, the PilotPreAPAD study, will be carried out to check whether the key parts of the planned Prevention in asymptomatic Arterial Disease (PreAPAD) study will work in practice. In phase one, it will test the screening process for asymptomatic arterial disease and the prevalence of the disease in the screened population to help estimate the sample size needed before starting the larger randomized multi centre PreAPAD study. In phase two, the pilot will test the study protocol, the data collection tools and how acceptable the intervention will be to participants. Peripheral artery disease is a disease where the arteries in the legs are narrowed by atherosclerosis causing pain in the affected limb during exercise and resting pain, ulcers and tissue loss in the more severe stage. Many people, however, are in the stage where they have no leg symptoms, even though they have narrowed arteries, the asymptomatic stage. Despite having no symptoms, they have almost double the risk of developing angina, heart attack, stroke, or dying prematurely-similar to those with more advanced disease. The disease can be easily detected by measuring the blood pressure in the ankle and comparing it to the blood pressure in the arm. This is called the Ankle-Brachial Index (ABI). Measuring ABI makes it possible to identify people at higher risk of future heart and vascular events-risks that can potentially be prevented. The PreAPAD study that is being planned aims to examine how preventive strategies affect heart- and other vascular events, quality of life, and disease progression in men and women with asymptomatic peripheral artery disease. Patients with diabetes, high blood pressure, COPD, or a history of smoking will be screened with ABI measurements to detect asymptomatic disease. The multimodal intervention that will be tested includes a health discussion with a nurse, participation in a health course, individualized exercise advice from a physiotherapist, exercise training, and medication to manage risk factors for cardiovascular disease if needed.