Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189111
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2005-09-12
Brief Title:
Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study
Sponsor:
Clinical Research Office Imaging Division
Organization:
UMC Utrecht
Study Overview
Official Title:
Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None