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Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms

11 december 2012 uppdaterad av: University of Edinburgh

Efficacy of Magnetic Resonance Imaging Using Ultrasmall Superparamagnetic Particles of Iron Oxide to Predict Clinical Outcome in Patients Under Surveillance for Abdominal Aortic Aneurysms

The aorta is the main blood vessel that comes out of the heart and distributes blood to the whole body. In some people, the aorta becomes swollen (aneurysm) and bursts, especially as it passes through the abdomen. These 'abdominal aortic aneurysms' often occur without symptoms and can burst or rupture without warning. This usually leads to death and represents the thirteenth commonest cause of death in the United Kingdom. In this study, we are looking at a new technique that can look at the aortic aneurysm using magnetic resonance imaging; a technique that does not require x-rays or radiation. We have recently shown that, using magnetic resonance combined with a new imaging agent USPIO, we can detect 'hotspots' of activity in these aneurysms that seem to predict which aneurysms grow rapidly, and are therefore potentially at risk of rupture. We here propose to conduct a study in Edinburgh that will invite all patients who are under surveillance because of an aneurysm. We will image these patients using this novel technique and see if we can identify which patients burst their aneurysm, have an aneurysm that grows so large it needs to have surgery, or die. This will be important to establish as it will potentially lead to a new way of managing people that could ultimately save lives. This is particularly timely as national screening and surveillance programmes are currently being launched.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

HYPOTHESIS We hypothesise that uptake of ultrasmall supraparamagnetic particles of iron oxide into the aortic wall will predict abdominal aortic aneurysm growth and clinical outcomes.

Studietyp

Observationell

Inskrivning (Faktisk)

16

Kontakter och platser

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

Studieorter

      • Edinburgh, Storbritannien, EH16 4SB
        • Clinical Research Imaging Centre/ NHS LOTHIAN

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

40 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

The investigators will recruit 237 patients with abdominal aortic aneurysms from the clinical surveillance programme at the Royal Infirmary, Edinburgh. Inclusion criteria will be patients with an abdominal aortic aneurysm >40 mm on ultrasound scanning. Exclusion criteria will include patients with anticipated or planned abdominal aortic aneurysm repair, women of child-bearing potential without contraception, inability to undergo magnetic resonance or computed tomography scanning, life expectancy of <2 years, and those with any form of collagen-vascular disease.

Beskrivning

Inclusion Criteria:

Patients with an abdominal aortic aneurysm >40 mm

Exclusion Criteria:

  1. Any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, or clinical laboratory examination that is deemed by the principal investigator and/or designee to make the subject ineligible for inclusion.
  2. Subjects with planned AAA surgery.
  3. Renal impairment with eGFR of <30 mls/min at screening, history of kidney transplant or history of contrast nephropathy.
  4. Women of child-bearing potential without contraception,
  5. Collagen-vascular disease.
  6. Inability to undergo magnetic resonance or computed tomography scanning,
  7. Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but not limited to:

    • Intracranial aneurysm clips (except Sugita) or other metallic objects,
    • History of intra- orbital metal fragments that have not been removed,
    • Pacemakers, implantable cardiac defibrillators and non-MR compatible heart valves,
    • Inner ear implants,
    • History of claustrophobia in MR.

Studieplan

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

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Abdominal Aortic Aneurysms
Patients will be recruited from the outpatient AAA surveillance population at the vascular unit in the Royal Infirmary of Edinburgh.Potential participation in the study will be completely asymptomatic from their AAA.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To determine if uptake ultrasmall superparamagnetic particles of iron oxide as determined by percentage R2* change between pre-and post-constant scan will predict abdominal aortic aneurysm growth and rupture in patients with abdominal aortic aneurysms.
Tidsram: 2 yrs
The change of R2* signal which is determined by the USPIO uptake within the issues will be used to assess the change between pre-and post contrast MRI scans. The investigators will assess if macrophage activity as determined by USPIO change predicts AAA growth and rupture
2 yrs
Does USPIO uptake as determined by percentage change between pre-and post contrast scan co-relates with FDG PET standardised uptake values or tissue to background ratios.
Tidsram: 2 yrs
As per ethical approval, we have recruited patients under AAA PET study to look at USPIO correlation with 18F-FDG PET. The cellular inflammation can be assessed by USPIO uptake, whilst the metabolic activity can be determined by 18F-FDG PET. In this study, the investigators will determine if there is a correlation between the these two imaging modalties by comparing the R2* change using MRI and standardised uptake values using FDG PET.
2 yrs

Samarbetspartners och utredare

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

Samarbetspartners

Utredare

  • Huvudutredare: David Newby, MD PhD, University of Edinburgh

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 mars 2011

Primärt slutförande (Faktisk)

1 augusti 2012

Avslutad studie (Faktisk)

1 augusti 2012

Studieregistreringsdatum

Först inskickad

30 november 2012

Först inskickad som uppfyllde QC-kriterierna

11 december 2012

Första postat (Uppskatta)

13 december 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 december 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 december 2012

Senast verifierad

1 december 2012

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2011/R1CARl05
  • 10336 (Registeridentifierare: UKRCN)

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