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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26430
Enrollment
1200
Registered
2005-09-12
Start date
2005-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peripheral arterial disease

Interventions

Patients randomized to the control group will ondergo a CT scan to determine the coronary calcium score
Patients in the intervention group will undergo a CTscan for calcium score, and a contrast enhanced CT scan for the evalluation of coronary stenosis. If no stenosis is found a dobutamine stress MRI o

Sponsors

None listed

Eligibility

Inclusion criteria

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

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 MRI examination; 6. Contra-indications to iodine contrast; 7. Severe arterial hypertension (>220/120 mmHg); 8. Significant aortic stenosis; 9. Unable to remain in supine position for at least 60 minutes; 10. Morbidly obese (BMI > 40); 11. Renal insufficiency (creatinine >140mmol/l); 12. Severe physical deterioration due to concomitant illness; 13. Language barrier; 14. Acute coronary syndrome. 15. Contra-indications to dobutamine.

Design outcomes

Primary

MeasureTime frame
Fatal and non-fatal myocardial infarction and stroke, and vascular death (death due to vascular disease).

Secondary

MeasureTime frame
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. Extra cranial hemorrhage; 8. Complications of CABG or PTCA; 9. All cause mortality.

Contacts

Public ContactA.M. Vos, de

University Medical Center Utrecht (UMCU), Housepost nr E.01.132, P.O. Box 85500

GROUND@azu.nl+31 (0)30 2509111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)