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

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ClinicalTrials.gov Identifier: NCT00189111
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Clinical Research Office Imaging Division, UMC Utrecht

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Procedure: Cardiac Imaging + Treatment Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study
Study Start Date : January 2005
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. cardiovascular mortality
  2. cardiovascular morbidity

Secondary Outcome Measures :
  1. Fatal and non-fatal myocardial infarction
  2. Fatal and non-fatal stroke
  3. Vascular interventions
  4. Amputation
  5. Aortic rupture
  6. End stage renal failure
  7. Extra cranial hemorrhage
  8. Complications of CABG or PTCA
  9. All cause mortality


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189111


Locations
Netherlands
Meander Medical Center
Amersfoort, Utrecht, Netherlands, 3800 BM
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM
Bronovo Hospital
The Hague, Zuid-Holland, Netherlands, 2597 AX
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
Clinical Research Office Imaging Division
Investigators
Principal Investigator: W. Mali, PhD UMC Utrecht
Principal Investigator: M. Oudkerk, PhD University Medical Center Groningen
Principal Investigator: M.L. Bots, PhD Julius Center, University Medical Center Utrecht
Principal Investigator: F. Zijlstra, PhD University Medical Center Groningen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Research Office Imaging Division, Clinical research coordinator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00189111     History of Changes
Other Study ID Numbers: METC.2004.100-GROUND
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: November 2016

Keywords provided by Clinical Research Office Imaging Division, 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