Peripheral Arterial Disease Clinical Trial
Official title:
Non-invasive Cardiac Screening in High Risk Patients -The GROUND Study
Verified date | November 2016 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to find out if subjecting cardiac high risk patients to non invasive cardiac imaging, followed by treatment will improve survival and quality of life
Status | Completed |
Enrollment | 1200 |
Est. completion date | April 2012 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Patients with peripheral arterial disease, diagnosed by the vascular surgeon - Patients must provide consent in writing after proper education and discussion with the treating physician and/or research physician - Patients must be aged 50 years or over Exclusion Criteria: - History of symptomatic cardiac disease - Cardiac rhythm other than sinus - Unable to sustain a breath-hold for 25 seconds - Asthma (contraindication beta-blockers) - Contra-indications to MRI examination. - Contra-indications to iodine contrast. - Severe arterial hypertension (>220/120 mmHg) - Significant aortic stenosis - Unable to remain in supine position for at least 60 minutes - Morbidly obese (BMI > 40) - Renal insufficiency (creatinine >140mmol/l) - Severe physical deterioration due to concomitant illness - Language barrier - Acute coronary syndrome - Contra-indications to dobutamine |
Country | Name | City | State |
---|---|---|---|
Netherlands | Meander Medical Center | Amersfoort | Utrecht |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | St. Antonius Hospital | Nieuwegein | Utrecht |
Netherlands | Bronovo Hospital | The Hague | Zuid-Holland |
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Clinical Research Office Imaging Division |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cardiovascular mortality | |||
Primary | cardiovascular morbidity | |||
Secondary | Fatal and non-fatal myocardial infarction | |||
Secondary | Fatal and non-fatal stroke | |||
Secondary | Vascular interventions | |||
Secondary | Amputation | |||
Secondary | Aortic rupture | |||
Secondary | End stage renal failure | |||
Secondary | Extra cranial hemorrhage | |||
Secondary | Complications of CABG or PTCA | |||
Secondary | All cause mortality |
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