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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by UMC Utrecht.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00189111
First received: September 12, 2005
Last updated: November 13, 2008
Last verified: November 2008
  Purpose

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


Condition Intervention Phase
Peripheral Arterial Disease
Procedure: Cardiac Imaging + Treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Non-Invasive Cardiac Screening in High Risk Patients -The GROUND Study

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • cardiovascular mortality
  • cardiovascular morbidity

Secondary Outcome Measures:
  • Fatal and non-fatal myocardial infarction
  • Fatal and non-fatal stroke
  • Vascular interventions
  • Amputation
  • Aortic rupture
  • End stage renal failure
  • Extra cranial hemorrhage
  • Complications of CABG or PTCA
  • All cause mortality

Estimated Enrollment: 1200
Study Start Date: January 2005
Estimated Study Completion Date: April 2012
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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189111

Contacts
Contact: W. Mali, PhD +31302506684 w.mali@azu.nl
Contact: A.M. de Vos, MD +31302506687 a.m.devos@azu.nl

Locations
Netherlands
Meander Medical Center Recruiting
Amersfoort, Utrecht, Netherlands, 3800 BM
Contact: A. Mosterd, PhD    +31334222469    a.mosterd@meandermc.nl   
Contact: R. Buiskool, PhD    +31334214526    R.Buiskool@meandermc.nl   
Principal Investigator: A. Mosterd, PhD         
Sub-Investigator: R. Buiskool, PhD         
Sub-Investigator: B Heggelman         
Sub-Investigator: A. Mackaay         
St. Antonius Hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3435 CM
Contact: B. Rensing, PhD    +31306099111    b.rensing@antonius.net   
Principal Investigator: B. Rensing, PhD         
Sub-Investigator: H. Van Es, PhD         
Sub-Investigator: H. Van Der Pavoordt, PhD         
Bronovo Hospital Recruiting
The Hague, Zuid-Holland, Netherlands, 2597 AX
Contact: P. Van Dijkman, PhD    +31703124365    pvdijkman@bronovo.nl   
Principal Investigator: P. Van Dijkman, PhD         
Sub-Investigator: Th. Kuijpers, PhD         
Sub-Investigator: H.J. Smeets, PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: M. Oudkerk, PhD    +31503614260    m.oudkerk@umcg.nl   
Contact: E. Noach, PhD    +31503619976    e.j.k.noach@rad.umcg.nl   
Principal Investigator: M. Oudkerk, PhD         
Sub-Investigator: F. Zijlstra, PhD         
Sub-Investigator: E. Noach, PhD         
Sub-Investigator: H.J. Van der Zaag, PhD         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Contact: W. Mali, PhD    +31302506684    w.mali@azu.nl   
Contact: A.M. De Vos, MD    +31302506687    a.m.devos@azu.nl   
Principal Investigator: W. Mali, PhD         
Sub-Investigator: W. Prokop, PhD         
Sub-Investigator: F. Moll, PhD         
Sub-Investigator: A. Rutten, MD         
Sub-Investigator: A.M. De Vos, MD         
Sub-Investigator: P.A. Doevendans, PhD         
Sub-Investigator: M. Cramer, PhD         
Sub-Investigator: M.L. Bots, PhD         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: W. Mali, PhD UMC Utrecht
Principal Investigator: M. Oudkerk, PhD University Medical Centre Groningen
Principal Investigator: M.L. Bots, PhD Julius Center, University Medical Center Utrecht
Principal Investigator: F. Zijlstra, PhD University Medical Centre Groningen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189111     History of Changes
Other Study ID Numbers: METC.2004.100-GROUND
Study First Received: September 12, 2005
Last Updated: November 13, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
peripheral arterial disease
computed tomography
cardiac asymptomatic
dobutamine magnetic resonance imaging

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014