Peripheral Arterial Disease Clinical Trial
Official title:
Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study
The purpose of this study is to find out if subjecting cardiac high risk patients to non invasive cardiac imaging, followed by treatment will improve survival and quality of life
Peripheral arterial disease (PAD) is a common disease associated with a considerably
increased risk of future events and with a high prevalence of coronary artery disease (CAD).
Improvement of the prognosis of this patient group is needed. Screening for CAD has become an
option with recent developments in CT-angiography and MR stress testing. It is unknown if
high-risk patient groups benefit from screening through non-invasive cardiac imaging.
Therefore we propose to study whether a cardiac imaging algorithm, using non-invasive imaging
techniques followed by evidence-based treatment will reduce the risk of cardiovascular
disease in cardiac asymptomatic PAD patients.
The GROUND study is designed as a prospective, multi-center, randomized clinical trial.
Patients with peripheral arterial disease, but yet without a history of symptomatic cardiac
disease will be asked to participate. All patients receive a proper therapeutic advice before
randomization. Half of the recruited patients will enter the 'control group' and only receive
CT calcium scoring. The other half of the recruited patients (index group) will undergo the
non invasive cardiac imaging algorithm followed by evidence-based treatment. First patients
undergo CT calcium scoring and CT angiography. Patients with a left main (or equivalent)
coronary artery stenosis on CT angiography will be referred to a cardiologist without further
imaging. All other patients in this group will undergo Dobutamine Stress Magnetic Resonance
(DSMR) testing. Patients with a DSMR positive for ischemia will also be referred to a
cardiologist. Most referred patients will very likely undergo conventional coronary artery
angiography and cardiac interventions (CABG or PCI) if indicated. All participants of the
trial will enter a 5 year follow up period for the occurrence of future cardiovascular
events. Interim analysis will take place and based on power calculations about 1200 patients
are needed to reach significance.
Implications The GROUND study will provide new insight into the question whether non-invasive
cardiac imaging reduces the risk of cardiovascular events in patients with peripheral
arterial disease, but yet without symptoms of coronary artery disease as an example of a high
risk patient group.
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