Non-invasive cardiac screening in patients with peripheral arterial disease: the GROUND study.
| ISRCTN | ISRCTN08433694 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08433694 |
| Secondary identifying numbers | NTR340 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 14/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr A.M. de Vos
Scientific
Scientific
University Medical Centre Utrecht (UMCU)
Housepost nr E.01.132
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 9111 |
|---|---|
| GROUND@azu.nl |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | |
| Study acronym | GROUND |
| 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. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Condition | Peripheral arterial disease (PAD), coronary artery stenosis |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Fatal and non-fatal myocardial infarction and stroke, and vascular death (death due to vascular disease). |
| 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. Extracranial haemorrhage 8. Complications of coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) 9. All cause mortality |
| Overall study start date | 01/01/2005 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1200 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/01/2005 |
| Recruitment end date | 31/12/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
Julius Centre for Health Sciences and Primary Care (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
University Medical Centre Utrecht (UMCU)
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2509358 |
|---|---|
| juliuscenter@azu.nl | |
| Website | http://www.juliuscentrum.nl/julius/ |
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Hospital/treatment centre
University Medical Centre Groningen (UMCG) (The Netherlands) - Department of Radiology
No information available
Julius Centre for Health Sciences and Primary Care (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
