The SMART-ORACLE Study (SMART-ORACLE)
|ClinicalTrials.gov Identifier: NCT01932671|
Recruitment Status : Unknown
Verified August 2013 by Prof. dr. Y. van der Graaf, UMC Utrecht.
Recruitment status was: Enrolling by invitation
First Posted : August 30, 2013
Last Update Posted : August 30, 2013
|Condition or disease|
|Coronary Artery Disease Stroke Peripheral Arterial Disease Hypertension Diabetes Mellitus, Type 2|
Patients with a prior cardiovascular event exhibit an elevated risk for subsequent cardiovascular events. The Second Manifestation of Arterial Disease Study (SMART) has recruited over 10,000 patients since 1996 with clinically manifest cardiovascular disease in a multidisciplinary single center study involving primary care physicians, cardiologists, neurologists, vascular surgeons, vascular medicine specialists and radiologists. Within this study a prediction model was developed to accurately estimate the risk for new cardiovascular events. It is now possible to acquire high-quality motion-free computed tomography (CT) images of the coronary and carotid arteries. Imaging biomarkers extracted from these images may further improve the prediction of future manifestations of arterial disease and personalize disease monitoring and medical care.
The SMART-ORACLE study is a prospective, single center, observational cohort study aiming to include 1500 patients. The primary aim is to identify predictors of future cardiovascular events. Eligible patients will be selected via the recruitment of the original SMART study. Patients participating in the SMART-ORACLE study will undergo calcium scoring in multiple cardiovascular beds and contrast-enhanced CT-scans of the coronary and carotid arteries in addition to the regular SMART investigations. Patients with renal dysfunction will be either excluded from the study or will receive pre-hydration (depending on eGFR) to minimize the risk of contrast nephropathy. Follow-up with questionnaire-based assessment will take place every 26 weeks until death of participant or end of the SMART study, asking participants about possible new cardiovascular events. Endpoints will be adjudicated by a committee of three experts. The aim is to collect 170 future events.
The main analysis will consist of Cox proportional hazard analysis. Imaging biomarkers will be added to the existing prediction model to assess their (independent) discriminatory capacity for future events. The c-statistic will be used to measure the discrimination of each model. Net reclassification improvement tables will be constructed to evaluate the added value of imaging markers in terms of reclassification. Based on a one-year-occurrence rate of subsequent cardiovascular events in the current SMART population database of 2.6%, about 6500 person years of follow-up are needed to obtain the adequate number of endpoints.
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||Optimising Risk Assessment With CT-angiography or Calcium Score in Patients at High Risk for a Cardiovascular Event|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||September 2016|
The SMART (Second Manifestation of ARTerial disease) cohort comprises patients at high-risk for or who have clinically manifest cardiovascular disease, including transient ischemic attack, cerebrovascular disease, peripheral artery disease, aneurysma aorta abdominalis, myocardial infarction, coronary ischemia for which coronary intervention is required, renal artery stenosis, diabetes mellitus, hyperlipidemia, hypertension, patients diagnosed with human immunodeficiency virus, pre-eclampsia, HELLP syndrome, abruption placentae and Intrauterine growth restriction in medical history. Participants are re-invited after 4 years for a second screening. This screening is performed to study the progression of atherosclerosis and evaluate the effects of the advice of the multidisciplinary team.
- Combined endpoint of cardiovascular events [ Time Frame: Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years ](non-fatal) ischemic stroke (non-fatal) myocardial infarction (cardio)vascular death Endpoints will be adjudicated by a committee of three experts.
- Carotid artery intervention [ Time Frame: Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years ]Carotid desobstruction or stenting
- Transient ischemic attack [ Time Frame: Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years ]
- Abdominal aorta aneurysm [ Time Frame: Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years ]Non-fatal rupture, stenting or operation of an abdominal aorta aneurysm
- Peripheral artery disease [ Time Frame: Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years ]Amputation, percutaneous transluminal angioplasty or stenting due to peripheral artery disease
- Coronary artery intervention [ Time Frame: Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years ]Percutaneous coronary intervention, coronary artery bypass graft
- All cause mortality [ Time Frame: Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932671
|Utrecht, Netherlands, 3508 GA|
|Principal Investigator:||Yolanda van der Graaf, Prof. dr.||UMC Utrecht|