Condition category
Circulatory System
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://jc.med.uu.nl/ground/

Contact information

Type

Scientific

Primary contact

Dr A.M. de Vos

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
Housepost nr E.01.132
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 9111
GROUND@azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR340

Study information

Scientific title

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

Received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2005

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

1200

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

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

Julius Centre for Health Sciences and Primary Care (The Netherlands)

Sponsor details

University Medical Centre Utrecht (UMCU)
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2509358
juliuscenter@azu.nl

Sponsor type

Hospital/treatment centre

Website

http://www.juliuscentrum.nl/julius/

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Groningen (UMCG) (The Netherlands) - Department of Radiology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Julius Centre for Health Sciences and Primary Care (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes