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

February 14, 2018 updated by: Clinical Research Office Imaging Division
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen
      • Utrecht, Netherlands, 3584CX
        • University Medical Center Utrecht
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3800 BM
        • Meander Medical Center
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • St. Antonius Hospital
    • Zuid-Holland
      • The Hague, Zuid-Holland, Netherlands, 2597 AX
        • Bronovo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
cardiovascular mortality
cardiovascular morbidity

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 16, 2005

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC.2004.100-GROUND

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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