Non-invasive cardiac screening in patients with peripheral arterial disease: the GROUND study.
| ISRCTN | ISRCTN08433694 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08433694 |
| Protocol serial number | NTR340 |
| Sponsor | Julius Centre for Health Sciences and Primary Care (The Netherlands) |
| Funders | University Medical Centre Groningen (UMCG) (The Netherlands) - Department of Radiology, Julius Centre for Health Sciences and Primary Care (The Netherlands) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | GROUND |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Fatal and non-fatal myocardial infarction and stroke, and vascular death (death due to vascular disease). |
| Key secondary outcome measure(s) |
1. Fatal and non-fatal myocardial infarction |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
