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The SMART-ORACLE Study (SMART-ORACLE)

27 augusti 2013 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

1500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Combined endpoint of cardiovascular events
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Carotid artery intervention
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

UMC Utrecht

Utredare

  • Huvudutredare: Yolanda van der Graaf, Prof. dr., UMC Utrecht

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2012

Primärt slutförande (Förväntat)

1 september 2016

Avslutad studie

7 december 2022

Studieregistreringsdatum

Först inskickad

18 augusti 2013

Först inskickad som uppfyllde QC-kriterierna

27 augusti 2013

Första postat (Uppskatta)

30 augusti 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

30 augusti 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 augusti 2013

Senast verifierad

1 augusti 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NL36828.041.11

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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