Clinical trial NCT00189111: Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study
Official title: Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Arterial Disease
Keywords: peripheral arterial disease
computed tomography
cardiac asymptomatic
dobutamine magnetic resonance imaging
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Patients with peripheral arterial disease, diagnosed by the vascular surgeon
* Patients must provide consent in writing after proper education and discussion with the treating physician and/or research physician
* Patients must be aged 50 years or over

Exclusion Criteria:

* History of symptomatic cardiac disease
* Cardiac rhythm other than sinus
* Unable to sustain a breath-hold for 25 seconds
* Asthma (contraindication beta-blockers)
* Contra-indications to MRI examination.
* Contra-indications to iodine contrast.
* Severe arterial hypertension (\>220/120 mmHg)
* Significant aortic stenosis
* Unable to remain in supine position for at least 60 minutes
* Morbidly obese (BMI \> 40)
* Renal insufficiency (creatinine \>140mmol/l)
* Severe physical deterioration due to concomitant illness
* Language barrier
* Acute coronary syndrome
* Contra-indications to dobutamine

Primary outcomes:
measure: cardiovascular mortality
measure: cardiovascular morbidity
Secondary outcomes:
measure: Fatal and non-fatal myocardial infarction
measure: Fatal and non-fatal stroke
measure: Vascular interventions
measure: Amputation
measure: Aortic rupture
measure: End stage renal failure
measure: Extra cranial hemorrhage
measure: Complications of CABG or PTCA
measure: All cause mortality
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medical Center
state: Utrecht
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
city: The Hague
country: Netherlands
facility: Bronovo Hospital
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: W. Mali, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: M. Oudkerk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Julius Center, University Medical Center Utrecht
name: M.L. Bots, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: F. Zijlstra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Vos AM, Rutten A, van de Zaag-Loonen HJ, Bots ML, Dikkers R, Buiskool RA, Mali WP, Lubbers DD, Mosterd A, Prokop M, Rensing BJ, Cramer MJ, van Es HW, Moll FL, van de Pavoordt ED, Doevendans PA, Velthuis BK, Mackaay AJ, Zijlstra F, Oudkerk M. Non-invasive cardiac assessment in high risk patients (The GROUND study): rationale, objectives and design of a multi-center randomized controlled clinical trial. Trials. 2008 Aug 1;9:49. doi: 10.1186/1745-6215-9-49.