Status:
COMPLETED
Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study
Lead Sponsor:
Clinical Research Office Imaging Division
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00189111
Start Date
January 1 2005
End Date
April 1 2012
Last Update
February 15 2018
Active Locations (5)
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1
Bronovo Hospital
The Hague, South Holland, Netherlands, 2597 AX
2
Meander Medical Center
Amersfoort, Utrecht, Netherlands, 3800 BM
3
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM
4
University Medical Center Groningen
Groningen, Netherlands, 9700 RB