on-invasive cardiac screening in patients with peripheral arterial disease: the GROUND study.

Completed

Conditions: Peripheral arterial disease (PAD), coronary artery stenosis
Circulatory System
Other peripheral vascular diseases

Registration Number: ISRCTN08433694

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1200

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatal and non-fatal myocardial infarction and stroke, and vascular death (death due to vascular disease).

Secondary Outcome Measures

Name	Time	Method
1. Fatal and non-fatal myocardial infarction <br>2. Fatal and non-fatal stroke<br>3. Vascular interventions<br>4. Amputation<br>5. Aortic rupture <br>6. End stage renal failure<br>7. Extracranial haemorrhage<br>8. Complications of coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA)<br>9. All cause mortality