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17 May 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Non-invasive cardiac screening in patients with peripheral arterial disease: the GROUND study. |
| ISRCTN | ISRCTN08433694 |
| ClinicalTrials.gov identifier | |
| Public title | Non-invasive cardiac screening in patients with peripheral arterial disease: the GROUND study. |
| Scientific title | |
| Acronym | GROUND |
| Serial number at source | NTR340 |
| Study hypothesis | Screening of asymptomatic coronary artery disease using non-invasive modalities in patients with manifestations of atherosclerosis, ie peripheral arterial disease (PAD), and subsequent treatment will result in a reduction of cardiac morbidity and mortality. |
| Lay summary | |
| Ethics approval | Received from the local medical ethics committee |
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Peripheral arterial disease (PAD), coronary artery stenosis |
| Participants - inclusion criteria |
1. PAD patients, stage Fontaine II (intermittent claudication) diagnosed by the vascular surgeon
2. Patients must provide consent in writing after proper education and discussion with the treating physician and/or research physician 3. Patients must be aged 50 years or over |
| Participants - exclusion criteria |
1. History of symptomatic cardiac disease
2. Cardiac rhythm other than sinus 3. Unable to sustain a breath-hold for 25 seconds 4. Asthma (contraindication beta-blockers) 5. Contra-indications to magnetic resonance imaging (MRI) examination 6. Contra-indications to iodine contrast 7. Severe arterial hypertension (greater than 220/120 mmHg) 8. Significant aortic stenosis 9. Unable to remain in supine position for at least 60 minutes 10. Morbidly obese (body mass index [BMI] greater than 40) 11. Renal insufficiency (creatinine greater than 140mmol/l) 12. Severe physical deterioration due to concomitant illness 13. Language barrier 14. Acute coronary syndrome 15. Contra-indications to dobutamine |
| Anticipated start date | 01/01/2005 |
| Anticipated end date | 31/12/2012 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 1200 |
| Interventions |
1. Patients randomised to the control group will undergo a computed tomography (CT) scan to determine the coronary calcium score
2. Patients in the intervention group will undergo a CT scan for calcium score, and a contrast enhanced CT scan for the evaluation of coronary stenosis. If no stenosis is found a dobutamine stress MRI of the heart will be performed to identify myocardial ischaemia. If a stenosis is found on either diagnostic test, the patient will be referred to the cardiologist, who will decide if and which treatment he will give the patient for the encountered coronary stenosis. |
| Primary outcome measure(s) | Fatal and non-fatal myocardial infarction and stroke, and vascular death (death due to vascular disease). |
| Secondary outcome measure(s) |
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. Extracranial haemorrhage 8. Complications of coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) 9. All cause mortality |
| Sources of funding |
1. University Medical Centre Groningen (UMCG) (The Netherlands) - Department of Radiology
2. Julius Centre for Health Sciences and Primary Care (The Netherlands) |
| Trial website | http://jc.med.uu.nl/ground/ |
| Publications | |
| Contact name | Dr A.M. de Vos |
| Address |
University Medical Centre Utrecht (UMCU)
Housepost nr E.01.132 P.O. Box 85500 |
| City/town | Utrecht |
| Zip/Postcode | 3508 GA |
| Country | Netherlands |
| Tel | +31 (0)30 250 9111 |
| GROUND@azu.nl | |
| Sponsor | Julius Centre for Health Sciences and Primary Care (The Netherlands) |
| Address |
University Medical Centre Utrecht (UMCU)
P.O. Box 85500 |
| City/town | Utrecht |
| Zip/Postcode | 3508 GA |
| Country | Netherlands |
| Tel | +31 (0)30 2509358 |
| Fax | +31 (0)30 505480 |
| juliuscenter@azu.nl | |
| Sponsor website: | http://www.juliuscentrum.nl/julius/ |
| Date applied | 20/12/2005 |
| Last edited | 14/11/2008 |
| Date ISRCTN assigned | 20/12/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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