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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189111
• Other study ID #: METC.2004.100-GROUND
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: February 14, 2018
• Start date: January 2005
• Est. completion date: April 2012

Study information

• Verified date: November 2016
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Cardiac Imaging + Treatment

Locations

Country	Name	City	State
Netherlands	Meander Medical Center	Amersfoort	Utrecht
Netherlands	University Medical Center Groningen	Groningen
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht
Netherlands	Bronovo Hospital	The Hague	Zuid-Holland
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Office Imaging Division

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular mortality
Primary	cardiovascular morbidity
Secondary	Fatal and non-fatal myocardial infarction
Secondary	Fatal and non-fatal stroke
Secondary	Vascular interventions
Secondary	Amputation
Secondary	Aortic rupture
Secondary	End stage renal failure
Secondary	Extra cranial hemorrhage
Secondary	Complications of CABG or PTCA
Secondary	All cause mortality