Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study

NCT ID: NCT00189111

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2012-04-30

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Cardiac Imaging + Treatment

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Research Office Imaging Division

OTHER

Sponsor Role: lead

Responsible Party

Clinical Research Office Imaging Division

Clinical research coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

W. Mali, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

M. Oudkerk, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

M.L. Bots, PhD

Role: PRINCIPAL_INVESTIGATOR

Julius Center, University Medical Center Utrecht

F. Zijlstra, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

Bronovo Hospital

The Hague, South Holland, Netherlands

Meander Medical Center

Amersfoort, Utrecht, Netherlands

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

University Medical Center Groningen

Groningen, , Netherlands

University Medical Center Utrecht

Utrecht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 18673542 (View on PubMed)

Other Identifiers

METC.2004.100-GROUND

Identifier Type: -

Identifier Source: org_study_id