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The SMART-ORACLE Study (SMART-ORACLE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Prof. dr. Y. van der Graaf, UMC Utrecht.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01932671
First Posted: August 30, 2013
Last Update Posted: August 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. dr. Y. van der Graaf, UMC Utrecht
August 18, 2013
August 30, 2013
August 30, 2013
August 2012
September 2016   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
The SMART-ORACLE Study
Optimising Risk Assessment With CT-angiography or Calcium Score in Patients at High Risk for a Cardiovascular Event
After having had a first cardiovascular event, there is a considerable risk of developing a subsequent event. Only recently, a risk prediction model was developed for this group of patients. Imaging techniques such as the coronary artery calcium score and contrast-enhanced computed tomography (CT) of the coronary and carotid arteries could be able to add improve this model. Imaging may further improve the prediction of future manifestations of arterial disease and personalize disease monitoring and treatment.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The study will be performed in consecutive patients entering the SMART study who are eligible according to the in- and exclusion criteria. SMART includes patients aged 18-79 years, who are newly referred to the University Hospital Utrecht with atherosclerotic cardiovascular disease insufficiency will be enrolled.
  • Coronary Artery Disease
  • Stroke
  • Peripheral Arterial Disease
  • Hypertension
  • Diabetes Mellitus, Type 2
Not Provided
SMART
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1500
Not Provided
September 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of cardiovascular event (coronary carter disease, cardiovascular disease, transient ischemic attack, minor stroke peripheral artery disease , abdominal aortic aneurysm)
  • Diabetes Mellitus type 2
  • Hypertension (Blood pressure>140/90 mm Hg)

Exclusion Criteria:

  • Known renal failure (defined as eGFR <46 ml/min/1.73 m2 estimated based on the modification of diet in renal disease (MDRD) formula)
  • Previous allergic reaction to contrast, necessitating medical intervention
  • Other contra-indication for CT-scanning (e.g. pregnancy, acute hypotension (<100 mm Hg systolic), clinical instability)
  • Prior exposure to ionizing radiation for scientific purposes without advantage for the patient
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01932671
NL36828.041.11
Yes
Not Provided
Not Provided
Prof. dr. Y. van der Graaf, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Yolanda van der Graaf, Prof. dr. UMC Utrecht
UMC Utrecht
August 2013