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The SMART-ORACLE Study (SMART-ORACLE)

27 août 2013 mis à jour par: Prof. dr. Y. van der Graaf, UMC Utrecht

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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

1500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Pays-Bas
- - Utrecht, Pays-Bas, 3508 GA
    - UMC Utrecht

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: Cohorte
Perspectives temporelles: Éventuel

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Groupe / Cohorte

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Combined endpoint of cardiovascular events Délai: 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.	Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Carotid artery intervention Délai: Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years	Carotid desobstruction or stenting	Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
Transient ischemic attack Délai: Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years		Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
Abdominal aorta aneurysm Délai: 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	Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
Peripheral artery disease Délai: 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	Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
Coronary artery intervention Délai: 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	Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
All cause mortality Délai: Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years		Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

UMC Utrecht

Les enquêteurs

Chercheur principal: Yolanda van der Graaf, Prof. dr., UMC Utrecht

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2012

Achèvement primaire (Anticipé)

1 septembre 2016

Achèvement de l'étude

7 décembre 2022

Dates d'inscription aux études

Première soumission

18 août 2013

Première soumission répondant aux critères de contrôle qualité

27 août 2013

Première publication (Estimation)

30 août 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

30 août 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 août 2013

Dernière vérification

1 août 2013

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

NL36828.041.11

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

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